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| eu mdr training course: Clinical Evaluation of Medical Devices Karen M. Becker, John J. Whyte, 2007-11-05 The original edition of this text, Clinical Evaluation of Medical Devices: Principles and Case Studies, provided the first overview of key pr- ciples and approaches to medical device clinical trials, illustrated with a series of detailed, real-world case studies. The book is designed as a resource for clinical professionals and regulatory specialists working in the field of new medical device development and marketing. Since the first edition of this text was published in 1997, the rapid pace of inno- tion in health care technologies continues to yield exciting and important new products. The regulatory landscape has also evolved, reflecting some of the changes and needs within the medical device industry. The purpose of Clinical Evaluation of Medical Devices: Principles and Case Studies, Second Edition is to provide an updated and expanded presentation of the scientific methods and regulatory requirements applied to the study of new significant risk medical devices. The text now includes (1) new information on the requirements and process for gaining reimbursement of new products from Medicare and private insurers, with case studies of research specifically designed for this p- pose as well as health care technology assessment methods; (2) infor- tion on new statistical methodologies applied to medical device trials; and (3) all new case studies, including examples of combination pr- ucts, three-phase development models (i. e. , feasibility, FDA approval, Medicare reimbursement), and novel study designs. |
| eu mdr training course: The Challenge of CMC Regulatory Compliance for Biopharmaceuticals John Geigert, 2019-05-08 Biopharmaceuticals (i.e., biological medicines sourced from genetically-engineered living systems) for treatment of human diseases have become a significant percentage of the pharmaceutical industry. And not just the recombinant DNA-derived proteins and monoclonal antibodies (both from the innovators and biosimilars); but now, an increasing awareness of the importance of gene therapy and genetically engineered cellular medicinal products. These biopharmaceuticals are being developed by many companies whose Chemistry, Manufacturing & Control (CMC) teams have varying degrees of familiarity or experience with the CMC strategy and regulatory compliance requirements for these challenging products. Companies clearly plan out the strategy for their clinical study plans, but frequently, the development of a strategy for CMC is an afterthought. Coupled with the complexity of the biopharmaceutical manufacturing processes and products, and this can be a recipe for disaster. The third edition of this book provides insights and practical guidance for the CMC teams to develop an acceptable cost-effective, risk-based CMC regulatory compliance strategy for all biopharmaceuticals (recombinant proteins, monoclonal antibodies, genetically engineered viruses and genetically engineered human cells) from early clinical stage development through market approval. The third edition of this book provides added coverage for the biosimilars, antibody drug conjugates (ADCs), bispecific antibodies, genetically engineered viruses, and genetically engineered cells. This third edition of the book also addresses the heightened pressure on CMC regulatory compliance timelines due to the introduction of expedited clinical pathways moving the clinical development closer to a seamless phase process (e.g., FDA Breakthrough Therapy designation, CBER Regenerative Medicine Advanced Therapy (RMAT) designation, EMA Priority Medicines (PRIME) designation). The Challenge of CMC Regulatory Compliance for Biopharmaceuticals is essential, practical information for all pharmaceutical development scientists, Manufacturing and Quality Unit staff, Regulatory Affairs personnel, and senior management involved in the manufacture of biopharmaceuticals. |
| eu mdr training course: 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 training course: 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! |
| eu mdr training course: 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 training course: 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 training course: 9th European Medical and Biological Engineering Conference Tomaž Jarm, |
| eu mdr training course: Novel Innovation Design for the Future of Health Michael Friebe, 2022-11-26 This book highlights the reasons for an urgently needed revision of the current global healthcare setup, discusses the needed mindset for a future of health, and provides a comprehensive development toolset for disruption (and for the needed incremental innovations towards disruption). Today’s biomedical and health innovation related research in universities encourages activities that lead to incremental innovations with a relatively low risk of failure. The healthcare industry on the other hand provides tools and devices for established healthcare providers to improve the diagnosis and therapy/ treatment of the patients’ health problems. The patient is not in the center of healthcare provision however, and prevention and prediction are not core goals. The current health setup needs to be challenged and disrupted. Disruptions are coming from technologies or processes that lead to a significant (>10x) reduction in cost or price/ performance and that also come with new business models. The need for change, effects of exponential technologies, and the needed shift to prevention and to homecare for health democratization and patient empowerment will be discussed in detail in the first parts of the book. The subsequent sections address several innovation methods with a focus on a novel meta methodology named Purpose Launchpad Health. This is followed by a comprehensive discussion on health entrepreneurship activities and needs. The final section of the book addresses how to train students to become entrepreneurial health innovators, presenting successful curricula and examples of health incubation and accelerator setups. All of the innovation tools presented and used in this book are summarized in the final chapter to help the reader get started planning an entrepreneurial venture. Written by experts from academia and industry, the book covers important basics and best practices, as well as recent developments. Chapters are concise and enriched with key messages, learning objectives and real innovation examples to bridge theory and practice. This book aims to serve as a teaching base for health innovation design and to prepare for health-related entrepreneurial ventures. Readers with medical, biomedical, biotechnology, and health economics backgrounds - and anyone who wants to become a future oriented health innovator or who believes in disruptive approaches - will find this book a useful resource and teaching tool for developing validated products/ services and processes for the future of health. |
| eu mdr training course: Data Protection and Privacy Dara Hallinan, Ronald Leenes, Paul de Hert, 2021-01-28 This book brings together papers that offer conceptual analyses, highlight issues, propose solutions, and discuss practices regarding privacy, data protection and Artificial Intelligence. It is one of the results of the thirteenth annual International Conference on Computers, Privacy and Data Protection (CPDP) held in Brussels in January 2020. The development and deployment of Artificial Intelligence promises significant break-throughs in how humans use data and information to understand and interact with the world. The technology, however, also raises significant concerns. In particular, concerns are raised as to how Artificial Intelligence will impact fundamental rights. This interdisciplinary book has been written at a time when the scale and impact of data processing on society – on individuals as well as on social systems – is becoming ever starker. It discusses open issues as well as daring and prospective approaches and is an insightful resource for readers with an interest in computers, privacy and data protection. |
| eu mdr training course: 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. |
| eu mdr training course: Dietary Reference Intakes for Vitamin A, Vitamin K, Arsenic, Boron, Chromium, Copper, Iodine, Iron, Manganese, Molybdenum, Nickel, Silicon, Vanadium, and Zinc Institute of Medicine, Food and Nutrition Board, Standing Committee on the Scientific Evaluation of Dietary Reference Intakes, Subcommittee of Interpretation and Uses of Dietary Reference Intakes, Subcommittee on Upper Reference Levels of Nutrients, Panel on Micronutrients, 2002-07-19 This volume is the newest release in the authoritative series issued by the National Academy of Sciences on dietary reference intakes (DRIs). This series provides recommended intakes, such as Recommended Dietary Allowances (RDAs), for use in planning nutritionally adequate diets for individuals based on age and gender. In addition, a new reference intake, the Tolerable Upper Intake Level (UL), has also been established to assist an individual in knowing how much is too much of a nutrient. Based on the Institute of Medicine's review of the scientific literature regarding dietary micronutrients, recommendations have been formulated regarding vitamins A and K, iron, iodine, chromium, copper, manganese, molybdenum, zinc, and other potentially beneficial trace elements such as boron to determine the roles, if any, they play in health. The book also: Reviews selected components of food that may influence the bioavailability of these compounds. Develops estimates of dietary intake of these compounds that are compatible with good nutrition throughout the life span and that may decrease risk of chronic disease where data indicate they play a role. Determines Tolerable Upper Intake levels for each nutrient reviewed where adequate scientific data are available in specific population subgroups. Identifies research needed to improve knowledge of the role of these micronutrients in human health. This book will be important to professionals in nutrition research and education. |
| eu mdr training course: Open Educational Practices and Resources Guntram Geser, 2007 |
| eu mdr training course: 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 training course: Artificial Intelligence in Healthcare Adam Bohr, Kaveh Memarzadeh, 2020-06-21 Artificial Intelligence (AI) in Healthcare is more than a comprehensive introduction to artificial intelligence as a tool in the generation and analysis of healthcare data. The book is split into two sections where the first section describes the current healthcare challenges and the rise of AI in this arena. The ten following chapters are written by specialists in each area, covering the whole healthcare ecosystem. First, the AI applications in drug design and drug development are presented followed by its applications in the field of cancer diagnostics, treatment and medical imaging. Subsequently, the application of AI in medical devices and surgery are covered as well as remote patient monitoring. Finally, the book dives into the topics of security, privacy, information sharing, health insurances and legal aspects of AI in healthcare. - Highlights different data techniques in healthcare data analysis, including machine learning and data mining - Illustrates different applications and challenges across the design, implementation and management of intelligent systems and healthcare data networks - Includes applications and case studies across all areas of AI in healthcare data |
| eu mdr training course: 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 training course: EDiR - The Essential Guide Judith Babar, Oğuz Dicle, Hildo J. Lamb, Laura Oleaga, Fermín Sáez, 2019-08-26 This EDiR guide has a practical rather than a theoretical focus, and is intended as a reference tool for potential EDiR candidates who would like to gain a better understanding of the EDiR examination. A pool of experts has made every possible effort to create a single source that contains everything needed to successfully pass the EDiR examination. Times have changed, and there is certainly a new generation of radiologists who will find this cutting-edge tool a “must-have” to familiarize themselves with the examination quickly and easily. The book is divided into the following main sections: one chapter for each subspecialty; one chapter on Safety, Management and Imaging Procedures; another on Principles of Imaging Techniques and Processing; and lastly, one on Management. This structure follows the same pattern as the EDiR examination, which is based on the European Training Curriculum (ETC) for Radiology released by the European Society of Radiology (ESR). Each subspecialty is covered using the same basic structure: Multiple Response Questions (MRQs), Short Cases (SCs) and CORE Cases from one of the most recent EDiR examinations. Students will thus be able to see all the questions from a recent examination and learn from the answers and comments provided by our pool of experts. Clinical cases as electronic supplementary material complete the book, and links to EDiR preparation sessions are also included, allowing students to improve their knowledge of specific areas. |
| eu mdr training course: The Quality System Compendium , 2015 |
| eu mdr training course: Antimicrobial Stewardship Céline Pulcini, Onder Ergonul, Fusun Can, Bojana Beović, 2017-04-05 Antimicrobial Stewardship (AMS), Volume Two includes the experience of ESGAP workshops and courses on antibiotic stewardship since 2012. It combines clinical and laboratory information about AMS, with a focus on human medicine. The ESCMID study group on antibiotic policies (ESGAP) is one of the most productive groups in the field, organizing courses and workshops. This book is an ideal tool for the participants of these workshops. With short chapters (around 1500 words) written on different topics, the authors insisted on the following points: A 'hands on', practical approach, tips to increase success, a description of the most common mistakes, a global picture (out- and inpatient settings, all countries) and a short list of 10-20 landmark references. - Focuses on the most recent antimicrobial stewardship strategies - Provides a detailed description of laboratory support - Offers a balanced synthesis of basic and clinical sciences for each individual case, presenting clinical courses of the cases in parallel with the pathogenesis and detailed microbiological information for each infection - Describes the prevalence and incidence of the global issues and current therapeutic approaches - Presents the measures for infection control |
| eu mdr training course: Patient Involvement in Health Technology Assessment Karen M. Facey, Helle Ploug Hansen, Ann N.V. Single, 2017-05-15 This is the first book to offer a comprehensive guide to involving patients in health technology assessment (HTA). Defining patient involvement as patient participation in the HTA process and research into patient aspects, this book includes detailed explanations of approaches to participation and research, as well as case studies. Patient Involvement in HTA enables researchers, postgraduate students, HTA professionals and experts in the HTA community to study these complementary ways of taking account of patients’ knowledge, experiences, needs and preferences. Part I includes chapters discussing the ethical rationale, terminology, patient-based evidence, participation and patient input. Part II sets out methodology including: Qualitative Evidence Synthesis, Discrete Choice Experiments, Analytical Hierarchy Processes, Ethnographic Fieldwork, Deliberative Methods, Social Media Analysis, Patient-Reported Outcome Measures, patients as collaborative research partners and evaluation. Part III contains 15 case studies setting out current activities by HTA bodies on five continents, health technology developers and patient organisations. Each part includes discussion chapters from leading experts in patient involvement. A final chapter reflects on the need to clearly define the goals for patient involvement within the context of the HTA to identify the optimal approach. With cohesive contributions from more than 80 authors from a variety of disciplines around the globe, it is hoped this book will serve as a catalyst for collaboration to further develop patient involvement to improve HTA. If you’re not involving patients, you're not doing HTA! - Dr. Brian O’Rourke, President and CEO of CADTH, Chair of INAHTA |
| eu mdr training course: Additive Manufacturing of Metals John O. Milewski, 2017-06-28 This engaging volume presents the exciting new technology of additive manufacturing (AM) of metal objects for a broad audience of academic and industry researchers, manufacturing professionals, undergraduate and graduate students, hobbyists, and artists. Innovative applications ranging from rocket nozzles to custom jewelry to medical implants illustrate a new world of freedom in design and fabrication, creating objects otherwise not possible by conventional means. The author describes the various methods and advanced metals used to create high value components, enabling readers to choose which process is best for them. Of particular interest is how harnessing the power of lasers, electron beams, and electric arcs, as directed by advanced computer models, robots, and 3D printing systems, can create otherwise unattainable objects. A timeline depicting the evolution of metalworking, accelerated by the computer and information age, ties AM metal technology to the rapid evolution of global technology trends. Charts, diagrams, and illustrations complement the text to describe the diverse set of technologies brought together in the AM processing of metal. Extensive listing of terms, definitions, and acronyms provides the reader with a quick reference guide to the language of AM metal processing. The book directs the reader to a wealth of internet sites providing further reading and resources, such as vendors and service providers, to jump start those interested in taking the first steps to establishing AM metal capability on whatever scale. The appendix provides hands-on example exercises for those ready to engage in experiential self-directed learning. |
| eu mdr training course: Emerging Infectious Diseases from the Global to the Local Perspective Institute of Medicine, Board on Global Health, Forum on Emerging Infections, 2001-03-29 In October 1999, the Forum on Emerging Infections of the Institute of Medicine convened a two-day workshop titled International Aspects of Emerging Infections. Key representatives from the international community explored the forces that drive emerging infectious diseases to prominence. Representatives from the Americas, Africa, Asia and the Pacific, and Europe made formal presentations and engaged in panel discussions. Emerging Infectious Diseases from the Global to the Local Perspective includes summaries of the formal presentations and suggests an agenda for future action. The topics addressed cover a wide range of issues, including trends in the incidence of infectious diseases around the world, descriptions of the wide variety of factors that contribute to the emergence and reemergence of these diseases, efforts to coordinate surveillance activities and responses within and across borders, and the resource, research, and international needs that remain to be addressed. |
| eu mdr training course: Usability Testing of Medical Devices Michael E. Wiklund, P.E., Jonathan Kendler, Allison Y. Strochlic, 2015-12-23 Usability Testing of Medical Devices covers the nitty-gritty of usability test planning, conducting, and results reporting. The book also discusses the government regulations and industry standards that motivate many medical device manufacturers to conduct usability tests.Since publication of the first edition, the FDA and other regulatory groups h |
| eu mdr training course: Be Ready for GDPR Punit Bhatia, 2017-08-04 Compliance to the General Data Protection Regulation (GDPR) is mandatory if your company is dealing with the personal data of EU residents. Compliance is not something to be left to chance. This book is designed to provide you with a step-by-step approach on how to structure a data protection plan can help you assure compliance. For those who already have a plan, this book will help review it and assure that the focus is assigned onto the right priorities. This book will provide answers to the following questions: * How to set your privacy and protection program?* How to structure your core team and governance?* What are the key roadmap tracks to ensure GDPR compliance?* What are the critical factors to assure GDPR compliance?* How to remain compliant in the longer term?Take the right step now. Buy this book now. |
| eu mdr training course: 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 training course: Toxicity Testing in the 21st Century National Research Council, Division on Earth and Life Studies, Institute for Laboratory Animal Research, Board on Environmental Studies and Toxicology, Committee on Toxicity Testing and Assessment of Environmental Agents, 2007-10-05 Advances in molecular biology and toxicology are paving the way for major improvements in the evaluation of the hazards posed by the large number of chemicals found at low levels in the environment. The National Research Council was asked by the U.S. Environmental Protection Agency to review the state of the science and create a far-reaching vision for the future of toxicity testing. The book finds that developing, improving, and validating new laboratory tools based on recent scientific advances could significantly improve our ability to understand the hazards and risks posed by chemicals. This new knowledge would lead to much more informed environmental regulations and dramatically reduce the need for animal testing because the new tests would be based on human cells and cell components. Substantial scientific efforts and resources will be required to leverage these new technologies to realize the vision, but the result will be a more efficient, informative and less costly system for assessing the hazards posed by industrial chemicals and pesticides. |
| eu mdr training course: Accuracy Requirements and Uncertainties in Radiotherapy International Atomic Energy Agency, 2017-04-12 Accuracy requirements in radiation oncology have been defined in multiple publications; however, these have been based on differing radiation technologies. In the meantime, the uncertainties in radiation dosimetry reference standards have been reduced and more detailed patient outcome data are available. No comprehensive literature on accuracy and uncertainties in radiotherapy has been published so far. The IAEA has therefore developed a new international consensus document on accuracy requirements and uncertainties in radiation therapy, to promote safer and more effective patient treatments. This publication addresses accuracy and uncertainty issues related to the vast majority of radiotherapy departments including both external beam radiotherapy and brachytherapy. It covers clinical, radiobiological, dosimetric, technical and physical aspects. |
| eu mdr training course: Good Laboratory Practice Regulations Allen F. Hirsch, 1989 |
| eu mdr training course: Radiation Protection and Safety of Radiation Sources International Atomic Energy Agency, 2014 This publication is the new edition of the International Basic Safety Standards. The edition is co-sponsored by seven other international organizations European Commission (EC/Euratom), FAO, ILO, OECD/NEA, PAHO, UNEP and WHO. It replaces the interim edition that was published in November 2011 and the previous edition of the International Basic Safety Standards which was published in 1996. It has been extensively revised and updated to take account of the latest finding of the United Nations Scientific Committee on the Effects of Atomic Radiation, and the latest recommendations of the International Commission on Radiological Protection. The publication details the requirements for the protection of people and the environment from harmful effects of ionizing radiation and for the safety of radiation sources. All circumstances of radiation exposure are considered. |
| eu mdr training course: Cyber Crisis Management Planning Jeffrey Don Crump, 2019 This book provides a step-by-step process an organization can follow to develop their own plan to minimize a major cyber incident with a framework for a cyber crisis management plan that digs into the details needed to build the plan. |
| eu mdr training course: Occupational Health & Safety Management Systems - Specification , 2002 |
| eu mdr training course: Engineering Open-Source Medical Devices Arti Ahluwalia, Carmelo De Maria, Andrés Díaz Lantada, 2022-02-23 This book focuses on the challenges and potentials of open source and collaborative design approaches and strategies in the biomedical field. It provides a comprehensive set of good practices and methods for making these safe, innovative and certifiable biomedical devices reach patients and provide successful solutions to healthcare issues. The chapters are sequenced to follow the complete lifecycle of open source medical technologies. The information provided is eminently practical, as it is supported by real cases of study, in which collaboration among medical professionals, engineers and technicians, patients and patient associations, policy makers, regulatory bodies, and citizens has proven beneficial. The book is also supported by an online infrastructure, UBORA, through which open-source medical devices can be collaboratively developed and shared for the democratization of medical technology and for promoting accessible biomedical engineering education. |
| eu mdr training course: Writing Human Factors Plans & Reports for Medical Technology Development Michael E. Wiklund, Laura Birmingham, Stephanie Alpert Larsen, 2018 |
| eu mdr training course: Software Verification and Validation for Practitioners and Managers Steven R. Rakitin, 2001 Suitable for software quality assurance professionals, software engineers, project managers and senior managers, this book is a concise and practical introduction to the basic principles of effective software verification and validation (V&V). This new edition has been thoroughly revised and includes five new chapters and five new appendices focused on management techniques to make your company's software V& V efforts more cost-effective. For Managers, you learn how to help your organization create more accurate estimates and schedules. For practitioners, you learn fundamental software verification and validation practices such as the formal inspection process, configuration management, effective testing techniques, and how to use measurements to drive further process improvements. |
| eu mdr training course: Take Control of Your Health Kendra Degen Pearsall, 2007 |
| eu mdr training course: Percutaneous Interventional Cardiovascular Medicine , 2012 |
| eu mdr training course: Validation of Computerized Analytical and Networked Systems Ludwig Huber, 2001-10-01 You cannot afford to be in the dark when it comes to validating your analytical systems and lab software. Written by international laboratory and compliance expert Dr. Ludwig Huber, Validation of Computerized Analytical and Networked Systems is an invaluable validation tool. Covering the initial writing of the validation plan through implementation, testing, and installation qualification, through ongoing calibration, performance qualification, and change control, the book provides guidance throughout the entire validation process. Huber pays special attention to 21CFR Part 11 electronic records and signatures compliance, including recommendations for implementation and the scope of Part 11 for chromatographic systems. He discusses vendor assessment, covers the criteria and procedures for vendor audits, and includes vendor assessment checklists. He also explores the validation of complex networked systems and office software such as Macros, spreadsheets, and databases, and the operational compliance of legacy systems. The book contains everything you need to perform computer systems validation cost-effectively and in a manner acceptable to national and international regulatory agencies. |
| eu mdr training course: Pharmaceutical Auditing Pharmaceutical Quality Group, 2001 |
| eu mdr training course: Science John Michels (Journalist), 2004 |
| eu mdr training course: Emerging Infectious Diseases , 2011 |
| eu mdr training course: Personalized Medicine in Healthcare Systems Nada Bodiroga-Vukobrat, Daniel Rukavina, Krešimir Pavelić, Gerald G. Sander, 2019-08-02 This book gathers scientific contributions on comprehensive approaches to personalized medicine. In a systematic and clear manner, it provides extensive information on the methodological, technological, and clinical aspects of high-throughput analytics, nanotechnology approaches, microbiota/human interactions, in-vitro fertilization and preimplantation, and various diseases like cancer.Moreover, the book analyzes the social and legal aspects of social security systems, healthcare systems and EU law – e.g. the role of solidarity, regulatory possibilities and obstacles, justice and equality, privacy/disclosure of data, and the right to know – from an interdisciplinary perspective. Lastly, it explores the economical and ethical context in the fields of business models, intellectual property issues, the patient/physician relationship, and price discrimination. |
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 (1,634,469 …
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 trade …
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 acts like a …
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 in …
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, and …
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.
