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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.

Health risk assessment. --- Medicine, Preventive --- Public health --- Risk assessment --- Environmental health --- Assessment, Health risk --- Health hazard appraisal --- Health hazard assessment --- Health risk appraisal --- HRA (Public health) --- Human risk assessment --- Risk Assessment --- Biomedical Technology --- Risk Management --- Health Risk Assessment --- Risks and Benefits --- Assessment, Risk --- Benefit-Risk Assessment --- Risk Analysis --- Risk-Benefit Assessment --- Analysis, Risk --- Assessment, Benefit-Risk --- Assessment, Health Risk --- Assessment, Risk-Benefit --- Benefit Risk Assessment --- Benefit-Risk Assessments --- Benefits and Risks --- Health Risk Assessments --- Risk Analyses --- Risk Assessment, Health --- Risk Assessments --- Risk Benefit Assessment --- Risk-Benefit Assessments --- legislation & jurisprudence --- organization & administration --- Medical instruments and apparatus industry --- Equipment Safety --- Risk management.

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Value in Health Regional Issues (ViHRI) is a new scientific journal of the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) to encourage and enhance the science of pharmacoeconomic/health economic and health outcomes research and its use in health care decisions in Asia, Latin America, Central & Eastern Europe, Western Asia, and Africa. Value in Health Regional Issues, a peer-reviewed publication, is an independent journal (unique ISSN), and is related to Value in Health only in cover design and contents. The scope and mission of Value in Health Regional Issues is consistent with the mission and scope of the Society. Value in Health Regional Issues includes articles on health care policy analysis, outcomes research (clinical, economic, and patient-reported) empirical studies, methodological studies, and articles on health care resources in the region. Health care decision-maker commentaries that stimulate communication between health outcomes researchers and policymakers are welcome. Commentaries are expected to include discussion on how researchers can better respond to the needs of those making clinical and financial decisions in health care.

Medical technology --- Regional planning --- Medical care --- Pharmaceutical technology --- Biotechnology --- Outcome Assessment (Health Care) --- Economics, Pharmaceutical. --- Technology, Medical --- Health Resources --- Risk Assessment. --- Evaluation --- standards. --- Economics, Pharmaceutical --- Risk Assessment --- standards --- Heatlh Risk Assessment --- Risks and Benefits --- Assessment, Risk --- Benefit-Risk Assessment --- Risk-Benefit Assessment --- Assessment, Benefit-Risk --- Assessment, Heatlh Risk --- Assessment, Risk-Benefit --- Assessments, Benefit-Risk --- Assessments, Heatlh Risk --- Assessments, Risk --- Assessments, Risk-Benefit --- Benefit Risk Assessment --- Benefit-Risk Assessments --- Benefits and Risks --- Heatlh Risk Assessments --- Risk Assessment, Heatlh --- Risk Assessments --- Risk Assessments, Heatlh --- Risk Benefit Assessment --- Risk-Benefit Assessments --- Resources --- Health Resource --- Resource --- Resource, Health --- Resources, Health --- Pharmaceutical Economics --- Pharmacoeconomics --- Pharmacy --- Assessment, Outcomes --- Outcome Measures --- Outcome Studies --- Outcomes Assessment --- Outcomes Research --- Assessment, Outcome (Health Care) --- Assessments, Outcome (Health Care) --- Assessments, Outcomes --- Measure, Outcome --- Measures, Outcome --- Outcome Assessments (Health Care) --- Outcome Measure --- Outcome Study --- Outcomes Assessments --- Research, Outcomes --- Studies, Outcome --- Study, Outcome --- Pharmaceutical laboratory techniques --- Pharmaceutical laboratory technology --- Technology, Pharmaceutical --- Delivery of health care --- Delivery of medical care --- Health care --- Health care delivery --- Health services --- Healthcare --- Medical and health care industry --- Medical services --- Personal health services --- Regional development --- State planning --- Health care technology --- Health technology --- economics --- Government policy --- Evaluation. --- Health Risk Assessment --- Assessment, Health Risk --- Assessments, Health Risk --- Health Risk Assessments --- Risk Assessment, Health --- Risk Assessments, Health --- Pharmacy Economics --- Economic, Pharmacy --- Economics, Pharmacy --- Pharmacy Economic --- Chemical engineering --- Genetic engineering --- Technology --- Public health --- Human settlements --- Land use --- Planning --- City planning --- Landscape protection --- Outcome Assessment, Health Care. --- Risk Analysis --- Analysis, Risk --- Risk Analyses --- Outcome Assessment, Health Care --- Medical Informatics

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Hygiene. Public health. Protection --- Outcome Assessment (Health Care) --- Economics, Pharmaceutical --- Health Resources --- Risk Assessment --- Technology, Medical --- Pharmaceutical services --- Outcome assessment (Medical care) --- Risk assessment --- Pharmacoéconomie --- Evaluation des résultats (Soins médicaux) --- Evaluation du risque --- Periodicals. --- standards --- Economic aspects --- Periodicals --- Périodiques --- Medical technology --- Medical care --- Pharmaceutical technology --- Biotechnology --- Economics, Pharmaceutical. --- Risk Assessment. --- Économie de la santé --- Politique de la santé --- Evaluation --- standards. --- Health Sciences --- Law --- Life Sciences --- Social Sciences --- General and Others --- Biology --- Public Policy & Administration --- Medical Laboratory Science --- Health Economics. --- Medical Technology. --- Evaluation. --- Electronic journals. --- Pharmaceutical laboratory techniques --- Pharmaceutical laboratory technology --- Technology, Pharmaceutical --- Delivery of health care --- Delivery of medical care --- Health care --- Health care delivery --- Health services --- Healthcare --- Medical and health care industry --- Medical services --- Personal health services --- Health care technology --- Health technology --- Heatlh Risk Assessment --- Risks and Benefits --- Assessment, Risk --- Benefit-Risk Assessment --- Risk-Benefit Assessment --- Assessment, Benefit-Risk --- Assessment, Heatlh Risk --- Assessment, Risk-Benefit --- Assessments, Benefit-Risk --- Assessments, Heatlh Risk --- Assessments, Risk --- Assessments, Risk-Benefit --- Benefit Risk Assessment --- Benefit-Risk Assessments --- Benefits and Risks --- Heatlh Risk Assessments --- Risk Assessment, Heatlh --- Risk Assessments --- Risk Assessments, Heatlh --- Risk Benefit Assessment --- Risk-Benefit Assessments --- Resources --- Health Resource --- Resource --- Resource, Health --- Resources, Health --- Pharmaceutical Economics --- Pharmacoeconomics --- Pharmacy --- Assessment, Outcomes --- Outcome Measures --- Outcome Studies --- Outcomes Assessment --- Outcomes Research --- Assessment, Outcome (Health Care) --- Assessments, Outcome (Health Care) --- Assessments, Outcomes --- Measure, Outcome --- Measures, Outcome --- Outcome Assessments (Health Care) --- Outcome Measure --- Outcome Study --- Outcomes Assessments --- Research, Outcomes --- Studies, Outcome --- Study, Outcome --- economics --- Cyber journals --- Cyber magazines --- Cyber periodicals --- Cyber serials --- E-journals --- Ejournals --- Electronic magazines --- Electronic periodicals --- Electronic serials --- Internet journals (Electronic publications) --- Internet magazines (Electronic publications) --- Internet periodicals (Electronic publications) --- Internet serials (Electronic publications) --- Online journals --- Online magazines --- Online periodicals --- Online serials --- Periodicals in machine-readable form --- Web journals (Electronic publications) --- Web magazines (Electronic publications) --- Web periodicals (Electronic publications) --- Web serials (Electronic publications) --- World Wide Web journals (Electronic publications) --- World Wide Web magazines (Electronic publications) --- World Wide Web periodicals (Electronic publications) --- World Wide Web serials (Electronic publications) --- Chemical engineering --- Genetic engineering --- Technology --- Public health --- Health Risk Assessment --- Assessment, Health Risk --- Assessments, Health Risk --- Health Risk Assessments --- Risk Assessment, Health --- Risk Assessments, Health --- Pharmacy Economics --- Economic, Pharmacy --- Economics, Pharmacy --- Pharmacy Economic --- Économie de la santé --- Politique de la santé --- Outcome Assessment, Health Care. --- Pharmacy, Therapeutics, & Pharmacology --- Risk Analysis --- Analysis, Risk --- Risk Analyses --- Biotechnology. --- methods. --- Biotechnologies --- Technologie médicale --- Soins médicaux --- Techniques pharmaceutiques --- Biotechnologie --- Évaluation --- Biomedical Technology --- Medical Informatics