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| eu mdr language requirements: Medical Devices and IVDs Wolfgang Ecker, 2022-03-25 With this book, you get a really complete seminar for the new Regulations on medical devices and IVDs in the EU, ready at hand, at any time. These EU regulations create new rules for medical technology and laboratory diagnostics in Europe. Concise regulatory know-how is now required to keep or reposition medical devices and in vitro diagnostics on the European market, from syringes, contact lenses, medical device apps, pregnancy tests, nuclear magnetic resonance tomography to cancer tests, genetic diagnostics, HIV tests, hip implants, heart catheters, artificial spinal discs, stents and pacemakers. Concise regulatory training and further education of employees in companies and health care facilities is the order of the day. This also applies to biomedical and medical technology students at universities of applied sciences and biomedical universities, start-ups and spin-offs, who must make use of this know-how from the initial product idea through the further stages of product development to market access. The book provides a thorough, compact course on the new regulations, starting with perfect overview and easy navigation and going into depth where you need it: this book will make you fit and confident for the new European challenges! 344 pages; 47 col. figures; 26 tables |
| eu mdr language requirements: European Medical Device Regulation (MDR) for MedTech and Medical Device Manufacturers Des O'Brien, 2019-04-05 The new European regulations on medical devices and in vitro medical devices were adopted on 05 April 2017 and came into force on 25th May 2017. Both these 2 new regulations replace and repeal Council Directives 90/385/EEC, 93/42/EEC Directive 98/79/EC and Commission Decision 2010/227/EU. This short book (approx 120 pages) provides a foundation overview of the new regulations and how they are structured. It must be stated that many notified bodies and companies provide insight and guidance online, this book provides a tangible resource for day to day use or for gaining an introduction to EU MDR, or alternatively as an ongoing quick reference guide. Although adopted and in force, the new rules shall only apply after a 3-year transitional period, whereby regulations will enter into force in April 2020 for medical devices and for five years after entry into force (April 2022) for the Regulation on in-vitro diagnostic medical devices. |
| eu mdr language requirements: The Combination Products Handbook Susan Neadle, 2023-05-16 Combination products are therapeutic and diagnostic products that combine drugs, devices, and/or biological products. According to the US Food and Drug Administration (FDA), “a combination product is one composed of any combination of a drug and a device; a biological product and a device; a drug and a biological product; or a drug, device and a biological product.” Examples include prefilled syringes, pen injectors, autoinjectors, inhalers, transdermal delivery systems, drug-eluting stents, and kits containing drug administration devices co-packaged with drugs and/or biological products. This handbook provides the most up-to-date information on the development of combination products, from the technology involved to successful delivery to market. The authors present important and up-to-the-minute pre- and post-market reviews of international combination product regulations, guidance, considerations, and best practices. This handbook: Brings clarity of understanding for global combination products guidance and regulations Reviews the current state-of-the-art considerations and best practices spanning the combination product lifecycle, pre-market through post-market Reviews medical product classification and assignment issues faced by global regulatory authorities and industry The editor is a recognized international Combination Products and Medical Device expert with over 35 years of industry experience and has an outstanding team of contributors. Endorsed by AAMI – Association for the Advancement of Medical Instrumentation. |
| eu mdr language requirements: Medical Device Regulations: Transitioning from MDD 93/42/EEC to MDR 2017/745 Shalinee Naidoo, 2020-11 In recent times the need for improving regulatory controls and finding ways to improve the quality and access to safe medical devices has increased. The Medical Devices Directive 93/42/EEC was enforced to provide a harmonised regulatory environment for all medical devices sold within the European Union however new and emerging technologies as well as various well-known incidents within the medical device industry have challenged the current framework and highlighted gaps and a scarcity of skills and expertise. For this reason, there has been an increasing need to update the MDD which led to the development and release of the Medical Device Regulation (EU MDR 2017/745). This has since marked the start of a three-year transition period for manufacturers, suppliers, Notified Bodies, and National Competent Authorities. While compliance to the new regulation was set to take effect in May of 2020, it has now been postponed by a year due to the recent coronavirus pandemic. This has essentially given manufacturers more time to assess their overall readiness and reprioritize the time-consuming areas of the transition. This volume aims to provide an easy-to-understand guide for beginners to the medical device regulations in Europe and looks specifically at the changes between the current Medical Device Directive 93/42/EEC and forthcoming Medical Devices Regulation (EU MDR 2017/745) with regards to classification, conformity assessments and assessing general safety and performance requirements. |
| eu mdr language requirements: Medical Regulatory Affairs Jack Wong, Raymond K. Y. Tong, 2022-01-27 This handbook covers medical device regulatory systems in different countries, ISO standards for medical devices, clinical trial and regulatory requirements, and documentation for application. It is the first to cover the medical device regulatory affairs in Asia. Experts from influential international regulatory bodies, including the US Food and Drug Administration (FDA), UK Medicines and Healthcare Products Regulatory Agency, Japan Pharmaceuticals and Medical Devices Agency, Saudi Food and Drug Authority, Korea Testing Laboratory, Taiwan FDA, World Health Organization, Asian Harmonization Working Party, Regulatory Affairs Professionals Society, and British Standards Institution, have contributed to the book. Government bodies, the medical device industry, academics, students, and general readers will find the book immensely useful for understanding the global regulatory environment and in their research and development projects. |
| eu mdr language requirements: Clinical Evaluation and Investigation of Medical Devices under the new EU-Regulation Wolfgang Ecker, Gerold Labek, Tarquin Mittermayr, Brigitte Raffeiner, Michael Ring, Bernhard Schwartz, 2020-06-04 The concept of clinical evaluation and the framework for clinical investigations have been significantly enforced within the new EU-Medical Device Regulation (MDR). This book provides in-depth and practice-oriented guidance on the systematic identification and generation of clinical data through clinical investigations and other relevant sources. It addresses the needs of all stakeholders, be it manufacturers, notified bodies or competent authorities, when they have to plan, perform or assess clinical evaluations and investigations for medical devices on the way to conformity assessment and CE marking. It is a valuable tool of qualification for clinicians and related experts when preparing for a role of a clinical evaluator in the field, either when serving any of the stakeholders or when trying to make their own involvement stand out in start-ups. spin-offs or other development projects or in counselling services. |
| eu mdr language requirements: Medical Devices and In Vitro Diagnostics Christian Baumgartner, Johann Harer, Jörg Schröttner, 2023-08-26 This updatable reference work gives a comprehensive overview of all relevant regulatory information and requirements for manufacturers and distributors around medical and in-vitro diagnostic devices in Europe. These individual requirements are presented in a practice-oriented manner, providing the reader with a concrete guide to implementation with main focus on the EU medical device regulations, such as MDR 2017/745 and IVD-R 2017/746, and the relevant standards, such as the ISO 13485, ISO 14971, among others. This book offers a good balance of expert knowledge, empirical values and practice-proven methods. Not only it provides readers with a quick overview about the most important requirements in the medical device sector, yet it shows concrete and proven ways in which these requirements can be implemented in practice. It addresses medical manufacturing companies, professionals in development, production, and quality assurance departments, and technical and medical students who are preparing themselves for a professional career in the medical technlogy industries. |
| eu mdr language requirements: Writing In-House Medical Device Software in Compliance with EU, UK, and US Regulations Philip S. Cosgriff, Matthew J. Memmott, 2024-03-26 This book is a comprehensive guide to producing medical software for routine clinical use. It is a practical guidebook for medical professionals developing software to ensure compliance with medical device regulations for software products intended to be sold commercially, shared with healthcare colleagues in other hospitals, or simply used in-house. It compares requirements and latest regulations in different global territories, including the most recent EU regulations as well as UK and US regulations. This book is a valuable resource for practising clinical scientists producing medical software in-house, in addition to other medical staff writing small apps for clinical use, clinical scientist trainees, and software engineers considering a move into healthcare. The academic level is post-graduate, as readers will require a basic knowledge of software engineering principles and practice. Key Features: Up to date with the latest regulations in the UK, the EU, and the US Useful for those producing medical software for routine clinical use Contains best practice |
| eu mdr language requirements: Electronic Government and the Information Systems Perspective Andrea Kő, Enrico Francesconi, 2016-08-06 This book constitutes the refereed proceedings of the 5th International Conference on Electronic Government and the Information Systems Perspective, EGOVIS 2016, held in Porto, Portugal, in September 2016, in conjunction with DEXA 2015. The 22 revised full papers presented together with three invited talk were carefully reviewed and selected from 27 submissions. The papers are organized in the following topical sections: e-government cases - legal issues; e-government cases - technical issues; open data and transparency; knowledge representation and modeling in e-government; intelligent systems in e-government; e-government research and intelligent systems; e-government data and knowledge management; identity management in e-government. |
| eu mdr language requirements: The ASQ Certified Medical Device Auditor Handbook Scott A Laman, 2021-02-05 The ASQ Certified Medical Device Auditor Handbook (formerly The Biomedical Quality Auditor Handbook) was developed by the ASQ Medical Device Division (formerly Biomedical Division) in support of its mission to promote the awareness and use of quality principles, concepts, and technologies in the medical device community. It principally serves as a resource to candidates preparing for the Certified Medical Device Auditor (CMDA) certification exam. The fourth edition of this handbook has been reorganized to align with the 2020 certification exam Body of Knowledge (BoK) and reference list. The combination of this handbook with other reference materials can provide a well-rounded background in medical device auditing. Updates to this edition include: • A discussion of data privacy, data integrity principles, and the Medical Device Single Audit Program (MDSAP) • Current information about federal and international regulations • New content regarding human factors and usability engineering, general safety and performance requirements, labeling, validation, risk management, and cybersecurity considerations • A thorough explanation of quality tools and techniques |
| eu mdr language requirements: Medical Devices Carlo Boccato, Sergio Cerutti, Joerg Vienken, 2022-02-24 This book provides caregivers and administrators with high-quality support for strategic decision making in the selection and use of medical devices so as to ensure value optimization. Medical treatment is increasingly complex, with wide application of medical devices and corresponding involvement of physics and engineering. A multidisciplinary methodology that brings together expertise from key disciplines in a holistic, system-oriented approach is essential in controlling this complexity and further improving health care. This book will help readers to understand the design, validation, and application of medical devices and the standards and regulations that apply to them across the world. In addition, it provides technical, operational, and economic perspectives on their use. The relevance of concepts such as expenditure optimization and sustainability to medical device technology is explained and healthcare reimbursement systems are discussed from different points of view. Readers will gain a clear appreciation of the managerial and economic implications of the use of medical devices and how to get the most out of them. Academic research, industrial experiences, and case studies are presented as appropriate. |
| eu mdr language requirements: The Future of Medical Device Regulation I. Glenn Cohen, Timo Minssen, W. Nicholson Price II, Christopher Robertson, Carmel Shachar, 2022-04-07 Regulators have been more permissive for medical devices compared to their drug and biologic counterparts. While innovative products can thereby reach consumers more quickly, this approach raises serious public health and safety concerns. Additionally, the nature of medical devices is rapidly changing, as software has become as important as hardware. Regulation must keep pace with the current developments and controversies of this technology. This volume provides a multidisciplinary evaluation of the ethical, legal, and regulatory concerns surrounding medical devices in the US and EU. For medical providers, policymakers, and other stakeholders, the book offers a framework for the opportunities and challenges on the horizon for medical device regulation. Readers will gain a nuanced overview of the latest developments in patient privacy and safety, innovation, and new regulatory laws. This book is also available as Open Access on Cambridge Core. |
| eu mdr language requirements: Planning, Writing and Reviewing Medical Device Clinical and Performance Evaluation Reports (CERs/PERs) Joy Frestedt, 2024-09-27 A Practical Guide to Planning, Writing, and Reviewing Medical Device Clinical Evaluation Reports guides readers through clinical data evaluation of medical devices, in compliance with the EU MDR requirements and other similar regulatory requirements throughout the world. This book brings together knowledge learned as the author constructed hundreds of CERs and taught thousands of learners on how to conduct clinical data evaluations. This book will support training for clinical engineers, clinical evaluation scientists, and experts reviewing medical device CERs, and will help individual writers, teams and companies to develop stronger, more robust CERs. Identifies and explains data analysis for clinical evaluation of medical devices Teaches readers how to understand and evaluate medical device performance and safety in the context of new regulations Provides analysis of new clinical evaluation criteria in the context of medical device design as well as in-hospital deployment and servicing |
| eu mdr language requirements: The Cambridge Handbook of Health Research Regulation Graeme Laurie, Edward Dove, Agomoni Ganguli-Mitra, Catriona McMillan, Emily Postan, Nayha Sethi, Annie Sorbie, 2021-06-24 The first ever interdisciplinary handbook in the field, this vital resource offers wide-ranging analysis of health research regulation. The chapters confront gaps between documented law and research in practice, and draw on legal, ethical and social theories about what counts as robust research regulation to make recommendations for future directions. The Handbook provides an account and analysis of current regulatory tools - such as consent to participation in research and the anonymization of data to protection participants' privacy - as well as commentary on the roles of the actors and stakeholders who are involved in human health research and its regulation. Drawing on a range of international examples of research using patient data, tissue and other human materials, the collective contribution of the volume is to explore current challenges in delivering good medical research for the public good and to provide insights on how to design better regulatory approaches. This title is also available as Open Access on Cambridge Core. |
| eu mdr language requirements: The EU General Data Protection Regulation (GDPR) Paul Voigt, Axel von dem Bussche, 2017-08-07 This book provides expert advice on the practical implementation of the European Union’s General Data Protection Regulation (GDPR) and systematically analyses its various provisions. Examples, tables, a checklist etc. showcase the practical consequences of the new legislation. The handbook examines the GDPR’s scope of application, the organizational and material requirements for data protection, the rights of data subjects, the role of the Supervisory Authorities, enforcement and fines under the GDPR, and national particularities. In addition, it supplies a brief outlook on the legal consequences for seminal data processing areas, such as Cloud Computing, Big Data and the Internet of Things.Adopted in 2016, the General Data Protection Regulation will come into force in May 2018. It provides for numerous new and intensified data protection obligations, as well as a significant increase in fines (up to 20 million euros). As a result, not only companies located within the European Union will have to change their approach to data security; due to the GDPR’s broad, transnational scope of application, it will affect numerous companies worldwide. |
| eu mdr language requirements: RISK MANAGEMENT FOR THE MEDICAL DEVICE INDUSTRY Dr. Akash Sharma, Ms. Vriti Gamta , Mr. Gaurav Luthra, 2023-07-25 Risk Management for the Medical Device Industry: A Guide based on ISO 14971 is an essential resource for professionals in the fast-paced medical device industry. Authored by Dr. Akash Sharma, Ms. Vriti Gamta, and Mr. Gaurav Luthra, experts in regulatory affairs and quality management systems, this practical guide offers comprehensive insights into risk management and compliance. Covering the entire risk management lifecycle, it includes case studies, best practices, and practical examples, along with discussions on integrating risk management with quality management systems and emerging technologies. Equip yourself with the knowledge and tools to ensure safety and effectiveness in the global market. |
| eu mdr language requirements: Safety Risk Management for Medical Devices Bijan Elahi, 2021-11-11 Safety Risk Management for Medical Devices, Second Edition teaches the essential safety risk management methodologies for medical devices compliant with the requirements of ISO 14971:2019. Focusing exclusively on safety risk assessment practices required in the MedTech sector, the book outlines sensible, easily comprehensible, state-of the-art methodologies that are rooted in current industry best practices, addressing safety risk management of medical devices, thus making it useful for those in the MedTech sector who are responsible for safety risk management or need to understand risk management, including design engineers, product engineers, development engineers, software engineers, Quality assurance and regulatory affairs. Graduate-level engineering students with an interest in medical devices will also benefit from this book. The new edition has been fully updated to reflect the state-of-the-art in this fast changing field. It offers guidance on developing and commercializing medical devices in line with the most current international standards and regulations. - Includes new coverage of ISO 14971:2019, ISO/TR 24971 - Presents the latest information on the history of risk management, lifetime of a medical device, risk management review, production and post production activities, post market risk management - Provides practical, easy-to-understand and state-of the-art methodologies that meet the requirements of international regulation |
| eu mdr language requirements: Advanced Additive Manufacturing Igor V. Shishkovsky, 2022-07-20 Additive manufacturing (AM) is now being used to produce series components for the most demanding applications. It is a disruptive, if not revolutionary, manufacturing technology. The biggest advantage of this technology is its capacity to make parts with any free form, thus paving the way for free and complex part design. Components and integrated structures with complex designs that would not have been possible just a few years ago can now be made according to various requirements. The net-shape manufacturing capacity of AM allows a considerable saving of materials, conventional thermomechanical processing, and machining processes, making it an environmentally friendly manufacturing technology. This book includes two sections that cover new approaches in AM for biomedical applications and advanced technological solutions. |
| eu mdr language requirements: Diagnostic Radiology Physics with MATLAB® Johan Helmenkamp, Robert Bujila, Gavin Poludniowski, 2020-11-23 Imaging modalities in radiology produce ever-increasing amounts of data which need to be displayed, optimized, analyzed and archived: a big data as well as an image processing problem. Computer programming skills are rarely emphasized during the education and training of medical physicists, meaning that many individuals enter the workplace without the ability to efficiently solve many real-world clinical problems. This book provides a foundation for the teaching and learning of programming for medical physicists and other professions in the field of Radiology and offers valuable content for novices and more experienced readers alike. It focuses on providing readers with practical skills on how to implement MATLAB® as an everyday tool, rather than on solving academic and abstract physics problems. Further, it recognizes that MATLAB is only one tool in a medical physicist’s toolkit and shows how it can be used as the glue to integrate other software and processes together. Yet, with great power comes great responsibility. The pitfalls to deploying your own software in a clinical environment are also clearly explained. This book is an ideal companion for all medical physicists and medical professionals looking to learn how to utilize MATLAB in their work. Features Encompasses a wide range of medical physics applications in diagnostic and interventional radiology Advances the skill of the reader by taking them through real-world practical examples and solutions with access to an online resource of example code The diverse examples of varying difficulty make the book suitable for readers from a variety of backgrounds and with different levels of programming experience. |
| eu mdr language requirements: Artificial Intelligence in Drug Development Kavita Sharma, |
| eu mdr language requirements: Health Policy and European Union Enlargement Mckee, 2004-04-01 While there may be consensus on the broader issues of the core objectives of the health care system, expectations differ between EU countries, and European national policy-makers. This book seeks firstly to assess the impact of the enlargement process and then to analyse the challenges that lie ahead in the field of health and health policy. |
| eu mdr language requirements: Electrical Product Compliance and Safety Engineering, Volume 2 Steli Loznen, Constantin Bolintineanu, 2021-09-30 |
| eu mdr language requirements: 8th European Medical and Biological Engineering Conference Tomaz Jarm, Aleksandra Cvetkoska, Samo Mahnič-Kalamiza, Damijan Miklavcic, 2020-11-29 This book aims at informing on new trends, challenges and solutions, in the multidisciplinary field of biomedical engineering. It covers traditional biomedical engineering topics, as well as innovative applications such as artificial intelligence in health care, tissue engineering , neurotechnology and wearable devices. Further topics include mobile health and electroporation-based technologies, as well as new treatments in medicine. Gathering the proceedings of the 8th European Medical and Biological Engineering Conference (EMBEC 2020), held on November 29 - December 3, 2020, in Portorož, Slovenia, this book bridges fundamental and clinically-oriented research, emphasizing the role of education, translational research and commercialization of new ideas in biomedical engineering. It aims at inspiring and fostering communication and collaboration between engineers, physicists, biologists, physicians and other professionals dealing with cutting-edge themes in and advanced technologies serving the broad field of biomedical engineering. |
| eu mdr language requirements: The Medical Devices (Amendment Etc. ) (EU Exit) Regulations 2020 GREAT BRITAIN., 2020-10-16 Enabling power: European Union (Withdrawal) Act 2018, ss. 8 (1), 8C, sch. 4, para. 1 (1) (ab), 7 (2), sch. 7, para. 21 & European Union (Withdrawal Agreement) Act 2020, s. 41 (1). Issued: 16.10.2020. Sifted: -. Made: -. Laid: -. Coming into force: In accord. with reg. 1 (2) (3). Effect: S.I. 2002/618; 2019/791, 1385 amended. Territorial extent & classification: E/W/S/NI. EC note: Directive 90/385; 93/42; 98/79 modified. For approval by resolution of each House of Parliament |
| eu mdr language requirements: The Development of Medical Devices Dirk Lanzerath, Sebastian von Kielmansegg, Joerg Hasford, 2020 Medical devices include objects, substances and software that are used for therapeutic or diagnostic purposes for humans. However, the main intended effect, in contrast to medicinal products, is not primarily pharmacological, metabolic or immunological, but usually physical or physicochemical. The innovation cycles for many modern implantable medical devices are estimated to be about 18 months, for software even shorter. It is obvious that the evaluation of the performance, the effectiveness, the benefits and risks of a medical devices is very different compared to medicinal products. The recent EU-Regulation on medical devices asks for very requirements regarding the systematic evaluation of medical devices in humans and the procedures for granting the CE mark. The recent volume of the series MEDICAL ETHICS addresses the ethical, legal, methodological, and practical challenges arising from the Regulation regarding the development and use of medical devices. |
| eu mdr language requirements: An Introduction to Assembly Language Programming and Computer Architecture Joe Carthy, 1996 This book is about two separate but related topics: assembly language programming and computer architecture. This is based on the notion that it is not possible to study computer architecture in any depth without some knowledge of assembly language programming and similarly, one of the reasons for studying assembly language programming is to gain an insight into how computers work - which naturally leads to their architecture. Introducing Assembly Language Programming and Computer Architecture is ideal for first year computer science or engineering students taking degree and diploma level courses. It will also be a useful reference for computer enthusiasts wishing to advance their knowledge and programming skills. |
| eu mdr language requirements: Emerging Fields in Easy Language and Accessible Communication Research Silvana Deilen, Silvia Hansen-Schirra, Sergio Hernández Garrido, Christiane Maaß, Anke Tardel, 2023-06-27 This volume presents current research and practices in the field of Easy Language and accessible communication. The publication of this volume was inspired by two international events, namely the International Easy Language Day Conference (IELD), and the panel The Social Role of Language: Translation into Easy and Plain Languages at the IATIS conference. By bringing together findings from different corpus-driven, cognitive and automation approaches in accessible communication research and providing insights into current projects of the emerging field of accessible health communication, the volume captures the dynamic and rapidly evolving nature of the field. |
| eu mdr language requirements: German Homoeopathic Pharmacopoeia , 2003-11-03 With the increased popularity of alternative medicine, quality assurance and testing methods for alternative medicinal products has moved to the forefront of the field. And although regulation of these products varies from country to country, universally they are required satisfy the same quality requirements as the medicines used in allopathy. Filling the need for an authoritative resource, German Homoeopathic Pharmacopoeia contains monographs covering homoeopathic products and their related analytical and manufacturing techniques. Each monograph is uniformly structured supplying, where applicable: Origin Description Characteristics Identification Purity Tests Assays Basic dosage forms Manufacture Storage Completely revised and updated, the volumes put the latest information within easy reach. An extensive collection of manufacturing and testing techniques, German Homoeopathic Pharmacopoeia establishes standards to ensure the pharmaceutical quality and safety of homoeopathic medicinal products. |
| eu mdr language requirements: Healthcare Technology Management - A Systematic Approach Francis Hegarty, John Amoore, Paul Blackett, Justin McCarthy, Richard Scott, 2017-01-06 Healthcare Technology Management: A Systematic Approach offers a comprehensive description of a method for providing safe and cost effective healthcare technology management (HTM). The approach is directed to enhancing the value (benefit in relation to cost) of the medical equipment assets of healthcare organizations to best support patients, clinicians and other care providers, as well as financial stakeholders. The authors propose a management model based on interlinked strategic and operational quality cycles which, when fully realized, delivers a comprehensive and transparent methodology for implementing a HTM programme throughout a healthcare organization. The approach proposes that HTM extends beyond managing the technology in isolation to include advancing patient care through supporting the application of the technology. The book shows how to cost effectively manage medical equipment through its full life cycle, from acquisition through operational use to disposal, and to advance care, adding value to the medical equipment assets for the benefit of patients and stakeholders. This book will be of interest to practicing clinical engineers and to students and lecturers, and includes self-directed learning questions and case studies. Clinicians, Chief Executive Officers, Directors of Finance and other hospital managers with responsibility for the governance of medical equipment will also find this book of interest and value. For more information about the book, please visit the website. |
| eu mdr language requirements: Classification of digital interventions, services and applications in health World Health Organization, 2023-10-24 |
| eu mdr language requirements: Registries for Evaluating Patient Outcomes Agency for Healthcare Research and Quality/AHRQ, 2014-04-01 This User’s Guide is intended to support the design, implementation, analysis, interpretation, and quality evaluation of registries created to increase understanding of patient outcomes. For the purposes of this guide, a patient registry is an organized system that uses observational study methods to collect uniform data (clinical and other) to evaluate specified outcomes for a population defined by a particular disease, condition, or exposure, and that serves one or more predetermined scientific, clinical, or policy purposes. A registry database is a file (or files) derived from the registry. Although registries can serve many purposes, this guide focuses on registries created for one or more of the following purposes: to describe the natural history of disease, to determine clinical effectiveness or cost-effectiveness of health care products and services, to measure or monitor safety and harm, and/or to measure quality of care. Registries are classified according to how their populations are defined. For example, product registries include patients who have been exposed to biopharmaceutical products or medical devices. Health services registries consist of patients who have had a common procedure, clinical encounter, or hospitalization. Disease or condition registries are defined by patients having the same diagnosis, such as cystic fibrosis or heart failure. The User’s Guide was created by researchers affiliated with AHRQ’s Effective Health Care Program, particularly those who participated in AHRQ’s DEcIDE (Developing Evidence to Inform Decisions About Effectiveness) program. Chapters were subject to multiple internal and external independent reviews. |
| eu mdr language requirements: Statistical Procedures for the Medical Device Industry Wayne A. Taylor, 2017 |
| eu mdr language requirements: Management of Legionella in Water Systems National Academies of Sciences, Engineering, and Medicine, Health and Medicine Division, Division on Earth and Life Studies, Board on Population Health and Public Health Practice, Board on Life Sciences, Water Science and Technology Board, Committee on Management of Legionella in Water Systems, 2020-02-20 Legionnaires' disease, a pneumonia caused by the Legionella bacterium, is the leading cause of reported waterborne disease outbreaks in the United States. Legionella occur naturally in water from many different environmental sources, but grow rapidly in the warm, stagnant conditions that can be found in engineered water systems such as cooling towers, building plumbing, and hot tubs. Humans are primarily exposed to Legionella through inhalation of contaminated aerosols into the respiratory system. Legionnaires' disease can be fatal, with between 3 and 33 percent of Legionella infections leading to death, and studies show the incidence of Legionnaires' disease in the United States increased five-fold from 2000 to 2017. Management of Legionella in Water Systems reviews the state of science on Legionella contamination of water systems, specifically the ecology and diagnosis. This report explores the process of transmission via water systems, quantification, prevention and control, and policy and training issues that affect the incidence of Legionnaires' disease. It also analyzes existing knowledge gaps and recommends research priorities moving forward. |
| eu mdr language requirements: Designing for Safe Use Michael Wiklund, Jonathan Kendler, Jon Tilliss, Cory Costantino, Kimmy Ansems, Valerie Ng, Ruben Post, Brenda van Geel, Rachel Aronchick, Alix Dorfman, 2019-03-11 How do you prevent a critical care nurse from accidentally delivering a morphine overdose to an ill patient? Or ensure that people don't insert their arm into a hydraulic mulcher? And what about enabling trapped airline passengers to escape safely in an emergency? Product designers and engineers face myriad such questions every day. Failure to answer them correctly can result in product designs that lead to injury or even death due to use error. Historically, designers and engineers have searched for answers by sifting through complicated safety standards or obscure industry guidance documents. Designing for Safe Use is the first comprehensive source of safety-focused design principles for product developers working in any industry. Inside you’ll find 100 principles that help ensure safe interactions with products as varied as baby strollers, stepladders, chainsaws, automobiles, apps, medication packaging, and even airliners. You’ll discover how protective features such as blade guards, roll bars, confirmation screens, antimicrobial coatings, and functional groupings can protect against a wide range of dangerous hazards, including sharp edges that can lacerate, top-heavy items that can roll over and crush, fumes that can poison, and small parts that can pose a choking hazard. Special book features include: Concise, illustrated descriptions of design principles Sample product designs that illustrate the book’s guidelines and exemplify best practices Literature references for readers interested in learning more about specific hazards and protective measures Statistics on the number of injuries that have arisen in the past due to causes that might be eliminated by applying the principles in the book Despite its serious subject matter, the book’s friendly tone, surprising anecdotes, bold visuals, and occasional attempts at dry humor will keep you interested in the art and science of making products safer. Whether you read the book cover-to-cover or jump around, the book’s relatable and practical approach will help you learn a lot about making products safe. Designing for Safe Use is a primer that will spark in readers a strong appreciation for the need to design safety into products. This reference is for designers, engineers, and students who seek a broad knowledge of safe design solutions. . |
| eu mdr language requirements: Fundamentals of Clinical Data Science Pieter Kubben, Michel Dumontier, Andre Dekker, 2018-12-21 This open access book comprehensively covers the fundamentals of clinical data science, focusing on data collection, modelling and clinical applications. Topics covered in the first section on data collection include: data sources, data at scale (big data), data stewardship (FAIR data) and related privacy concerns. Aspects of predictive modelling using techniques such as classification, regression or clustering, and prediction model validation will be covered in the second section. The third section covers aspects of (mobile) clinical decision support systems, operational excellence and value-based healthcare. Fundamentals of Clinical Data Science is an essential resource for healthcare professionals and IT consultants intending to develop and refine their skills in personalized medicine, using solutions based on large datasets from electronic health records or telemonitoring programmes. The book’s promise is “no math, no code”and will explain the topics in a style that is optimized for a healthcare audience. |
| eu mdr language requirements: Risk Management for Medical Device Manufacturers Joe W. Simon, 2022-01-20 As a quality professional in the medical device industry, you know all too well the importance of a risk management process-and how iterative it can be. Industry regulations and standards-like ISO 14971-help medical device manufacturers define risk management processes, but they don't make them bulletproof, that is, ensure the efficacy of their products while minimizing future liability. This book can help you build a bulletproof, risk process. You will learn how: Designing product and manufacturing processes controls risks Using consistent language in a holistic, closed-loop risk management system leads to greater efficiency Creating useable and audit-ready risk documents can support verification/validation (V/V) sampling plans Developing labels and instructions can help end-users and patients clearly understand the pertinent risks Creating post-market surveillance (PMS) processes is essential to determine if additional clinical/performance studies are necessary Joe Simon holds an MBA and has been a member of ASQ since 2008. Over his nearly 30-year career, he worked with numerous companies as an employee and a consultant to build or improve complaint analysis, trending, post-market surveillance (PMS), nonconformance (NC), corrective action/preventive action (CAPA), stewardship, and risk management processes. |
| eu mdr language requirements: The Ethics of Cybersecurity Markus Christen, Bert Gordijn, Michele Loi, 2020-02-10 This open access book provides the first comprehensive collection of papers that provide an integrative view on cybersecurity. It discusses theories, problems and solutions on the relevant ethical issues involved. This work is sorely needed in a world where cybersecurity has become indispensable to protect trust and confidence in the digital infrastructure whilst respecting fundamental values like equality, fairness, freedom, or privacy. The book has a strong practical focus as it includes case studies outlining ethical issues in cybersecurity and presenting guidelines and other measures to tackle those issues. It is thus not only relevant for academics but also for practitioners in cybersecurity such as providers of security software, governmental CERTs or Chief Security Officers in companies. |
| eu mdr language requirements: Future Tech Trond Arne Undheim, 2021-03-03 Amazon's Fire phone. Google Glass. Facebook Home. Quikster. New technologies alone don't always cause industry changes. Future Tech explains how the four forces of technology, policy, business models and social dynamics work together to create industry disruption and how this understanding can help to predict what is coming next. Technology is generally viewed as the single force that disrupts markets. However, history is rife with stories of technologies that have failed to meet such hyped expectations. In Future Tech, the author reveals that true change only results from combining the forces of science and technology, policy and regulation, new business models (i.e. sharing economy) and social dynamics (whether or not people adopt it). Whether these four forces align explains why some technologies, such as AI, blockchain, robotics, synthetic biology and 3D printing, stick and why others fail. With an understanding of these four forces, business executives and policymakers can explain what technology is likely to stick and even anticipate what is coming next. By 2030, the global labor force will be led by an elite set of knowledge workers enabled by robotic AI. To help individuals thrive in this workplace, Future Tech advises readers to develop their human capabilities of creativity and adaptation, develop deep expertise in one domain while being well-versed in dozens more, and develop a personalized approach to acquiring and processing information and deliberating decisions. |
| eu mdr language requirements: Medical Device Design , 2012-12-17 This book provides the bridge between engineering design and medical device development. There is no single text that addresses the plethora of design issues a medical devices designer meets when developing new products or improving older ones. It addresses medical devices' regulatory (FDA and EU) requirements--some of the most stringent engineering requirements globally. Engineers failing to meet these requirements can cause serious harm to users as well as their products’ commercial prospects. This Handbook shows the essential methodologies medical designers must understand to ensure their products meet requirements. It brings together proven design protocols and puts them in an explicit medical context based on the author's years of academia (R&D phase) and industrial (commercialization phase) experience. This design methodology enables engineers and medical device manufacturers to bring new products to the marketplace rapidly. The medical device market is a multi-billion dollar industry. Every engineered product for this sector, from scalpelsstents to complex medical equipment, must be designed and developed to approved procedures and standards. This book shows how Covers US, and EU and ISO standards, enabling a truly international approach, providing a guide to the international standards that practicing engineers require to understand Written by an experienced medical device engineers and entrepreneurs with products in the from the US and UK and with real world experience of developing and commercializing medical products |
| eu mdr language requirements: Risk Assessment in the Federal Government National Research Council, Division on Earth and Life Studies, Commission on Life Sciences, Committee on the Institutional Means for Assessment of Risks to Public Health, 1983-02-01 The regulation of potentially hazardous substances has become a controversial issue. This volume evaluates past efforts to develop and use risk assessment guidelines, reviews the experience of regulatory agencies with different administrative arrangements for risk assessment, and evaluates various proposals to modify procedures. The book's conclusions and recommendations can be applied across the entire field of environmental health. |
European Union - Wikipedia
The European Union (EU) is a supranational political and economic union of 27 member states that are located primarily in Europe. [8] [9] The union has a total area of 4,233,255 km 2 …
Your gateway to the EU, News, Highlights | European Union
Jun 6, 2025 · Find out how many EU Member States there are, how big the EU economy is, how people live in the EU, and other useful facts about the EU. Discover what the EU does for …
European Union (EU) | Definition, Flag, Purpose, History,
2 days ago · The European Union (EU) is an international organization that governs economic, social, and security policies common to its 27 member countries. The EU was created by the …
European Union (EU): What It Is, Countries, History, Purpose - Investopedia
Dec 14, 2023 · The European Union (EU) is a political and economic alliance of 27 countries. It promotes democratic values in its member nations and is one of the world's most powerful …
European Union - Simple English Wikipedia, the free encyclopedia
The European Union (abbreviation: EU) is a union of 27 member countries in Europe.It was created by the Maastricht Treaty in 1993. It is a unique political organisation; in some ways, it …
The EU - what it is and what it does - EU Publications
This publication is a guide to the European Union (EU) and what it does. The first section briefly explains what the EU is. The second section, ‘What the European Union does’, describes what …
What Is the European Union? - The Balance
Apr 28, 2022 · The EU provides for open borders between its member countries to facilitate trade without tariffs or duties. The Treaty of Maastricht formed the European Union common market …
EU countries - European Union
Use the map and list below to explore the countries of the European Union. Find out when they joined the EU, Schengen or the euro, and learn more about the country on the dedicated page.
European Union - Definition, Flag, History - Corporate Finance …
The European Union (EU) is a unified organization of 27 member states, with authority over their political, economic, and social policies. The EU aims to ensure peace, encourage free trade, …
How the European Union works | Fact Sheets on the
Read about how the EU works. Fact Sheets provide an overview of European integration and the role of the European Parliament.
European Union - Wikipedia
The European Union (EU) is a supranational political and economic union of 27 member states that are located primarily in Europe. [8] [9] The union has a total area of 4,233,255 km 2 …
Your gateway to the EU, News, Highlights | European Union
Jun 6, 2025 · Find out how many EU Member States there are, how big the EU economy is, how people live in the EU, and other useful facts about the EU. Discover what the EU does for …
European Union (EU) | Definition, Flag, Purpose, History,
2 days ago · The European Union (EU) is an international organization that governs economic, social, and security policies common to its 27 member countries. The EU was created by the …
European Union (EU): What It Is, Countries, History, Purpose - Investopedia
Dec 14, 2023 · The European Union (EU) is a political and economic alliance of 27 countries. It promotes democratic values in its member nations and is one of the world's most powerful …
European Union - Simple English Wikipedia, the free encyclopedia
The European Union (abbreviation: EU) is a union of 27 member countries in Europe.It was created by the Maastricht Treaty in 1993. It is a unique political organisation; in some ways, it …
The EU - what it is and what it does - EU Publications
This publication is a guide to the European Union (EU) and what it does. The first section briefly explains what the EU is. The second section, ‘What the European Union does’, describes what …
What Is the European Union? - The Balance
Apr 28, 2022 · The EU provides for open borders between its member countries to facilitate trade without tariffs or duties. The Treaty of Maastricht formed the European Union common market …
EU countries - European Union
Use the map and list below to explore the countries of the European Union. Find out when they joined the EU, Schengen or the euro, and learn more about the country on the dedicated page.
European Union - Definition, Flag, History - Corporate Finance …
The European Union (EU) is a unified organization of 27 member states, with authority over their political, economic, and social policies. The EU aims to ensure peace, encourage free trade, …
How the European Union works | Fact Sheets on the
Read about how the EU works. Fact Sheets provide an overview of European integration and the role of the European Parliament.
