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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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Reliability, Maintainability and Risk: Practical Methods for Engineers, Ninth Edition, has taught reliability and safety engineers techniques to minimize process design, operation defects, and failures for 35 years. For beginners, the book provides tactics on how to avoid pitfalls in this complex and wide field. For experts in the field, well-described, realistic, and illustrative examples and case studies add new insight and assistance. The author uses his 40 years of experience to create a comprehensive and detailed guide to the field, also providing an excellent description of reliability and risk computation concepts. The book is organized into five parts. Part One covers reliability parameters and costs traces the history of reliability and safety technology, presenting a cost-effective approach to quality, reliability, and safety. Part Two deals with the interpretation of failure rates, while Part Three focuses on the prediction of reliability and risk. Part Four discusses design and assurance techniques, review and testing techniques, reliability growth modeling, field data collection and feedback, predicting and demonstrating repair times, quantified reliability maintenance, and systematic failures, while Part 5 deals with legal, management and safety issues, such as project management, product liability, and safety legislation. Additional chapter on helicopter and aviation safety record Coverage of models for partial valve stroke test, fault tree logic and quantification difficulties More detail on use of tools such as FMEDA and programming standards like MISRA

Engineering sciences. Technology --- Production management --- veiligheid (technologie) --- procesindustrie --- Reliability (Engineering) --- Maintainability (Engineering) --- Engineering design --- Engineering --- Reproducibility of Results --- Risk Assessment --- 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 --- Face Validity --- Reliability (Epidemiology) --- Reliability of Results --- Reproducibility of Findings --- Test-Retest Reliability --- Validity (Epidemiology) --- Reliability and Validity --- Reliability of Result --- Reproducibility Of Result --- Reproducibility of Finding --- Validity of Result --- Validity of Results --- Finding Reproducibilities --- Finding Reproducibility --- Of Result, Reproducibility --- Of Results, Reproducibility --- Reliabilities, Test-Retest --- Reliability, Test-Retest --- Result Reliabilities --- Result Reliability --- Result Validities --- Result Validity --- Result, Reproducibility Of --- Results, Reproducibility Of --- Test Retest Reliability --- Validity and Reliability --- Validity, Face --- Engineerings --- Design, Engineering --- Industrial design --- Strains and stresses --- Maintainability of equipment --- Serviceability (Engineering) --- Operations research --- Systems engineering --- Reliability of equipment --- Systems reliability --- Probabilities --- Plant performance --- Safety factor in engineering --- Structural failures --- Design --- E-books --- Engineering design. --- Fiabilité --- Maintenabilité --- Conception technique --- Risk assessment. --- Risk analysis --- Risk evaluation --- Evaluation

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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

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The chapters in this topical volume of Advances in Microbiology, Infectious Diseases and Public Health present exciting, insightful observations on emerging viral infections like influenza, Middle East respiratory syndrome, or mosquito-transmitted diseases, as well as the potential of social media in preventing and fighting infectious diseases. This rapidly developing field of study, which involves interdisciplinary and challenging research conducted in both industrialized and limited-resource countries, can yield vital information for the life and social sciences, for public health, and for healthcare in general. The aim of this volume is to contribute to the development of knowledge on emerging infections in the endless struggle between viruses and man. The chapters selected are not intended as a systematic collection of all emerging infections, but instead highlight recent discoveries and provide insights on today’s hot topics. The book offers a valuable resource for all scientists working in the field of emerging viral infections and possible vaccines, as well as for laboratory and medical staff whose work involves preventing, controlling and combatting infectious diseases.

Medicine. --- Virology. --- Microbiology. --- Biomedicine. --- Virus diseases. --- Emerging infectious diseases. --- Emerging infections --- New infectious diseases --- Re-emerging infectious diseases --- Reemerging infectious diseases --- Viral diseases --- Viral infections --- Virus infections --- Microbial biology --- Biology --- Microorganisms --- Microbiology --- Clinical sciences --- Medical profession --- Human biology --- Life sciences --- Medical sciences --- Pathology --- Physicians --- Communicable diseases --- Medical virology --- Pathogenic viruses --- Medical virology. --- Medical microbiology --- Virology --- Virus diseases --- Virus Diseases. --- Communicable Diseases, Emerging. --- Communicable Diseases. --- Epidemics. --- Global Health. --- Risk Assessment. --- Vaccination. --- Immunization, Active --- Active Immunization --- Active Immunizations --- Immunizations, Active --- Vaccinations --- Health Risk Assessment --- Risks and Benefits --- Assessment, Risk --- Benefit-Risk Assessment --- Risk-Benefit Assessment --- Assessment, Benefit-Risk --- Assessment, Health Risk --- Assessment, Risk-Benefit --- Assessments, Benefit-Risk --- Assessments, Health Risk --- Assessments, Risk --- Assessments, Risk-Benefit --- Benefit Risk Assessment --- Benefit-Risk Assessments --- Benefits and Risks --- Health Risk Assessments --- Risk Assessment, Health --- Risk Assessments --- Risk Assessments, Health --- Risk Benefit Assessment --- Risk-Benefit Assessments --- International Health --- Worldwide Health --- International Health Problems --- World Health --- Health Problem, International --- Health Problems, International --- Health, Global --- Health, International --- Health, World --- Health, Worldwide --- Healths, International --- International Health Problem --- International Healths --- Problem, International Health --- Problems, International Health --- World Health Organization --- Epidemic --- Infectious Diseases --- Communicable Disease --- Disease, Communicable --- Disease, Infectious --- Diseases, Communicable --- Diseases, Infectious --- Infectious Disease --- Disease Outbreaks --- Disease Transmission, Infectious --- Communicable Diseases, Re-Emerging --- Communicable Diseases, Reemerging --- Infectious Diseases, Re-Emerging --- Infectious Diseases, Reemerging --- Infectious Diseases, Emerging --- Communicable Disease, Emerging --- Communicable Disease, Re-Emerging --- Communicable Disease, Reemerging --- Communicable Diseases, Re Emerging --- Disease, Emerging Communicable --- Disease, Emerging Infectious --- Disease, Re-Emerging Communicable --- Disease, Re-Emerging Infectious --- Disease, Reemerging Communicable --- Disease, Reemerging Infectious --- Diseases, Emerging Communicable --- Diseases, Emerging Infectious --- Diseases, Re-Emerging Communicable --- Diseases, Re-Emerging Infectious --- Diseases, Reemerging Communicable --- Diseases, Reemerging Infectious --- Emerging Communicable Disease --- Emerging Communicable Diseases --- Emerging Infectious Disease --- Emerging Infectious Diseases --- Infectious Disease, Emerging --- Infectious Disease, Re-Emerging --- Infectious Disease, Reemerging --- Infectious Diseases, Re Emerging --- Re-Emerging Communicable Disease --- Re-Emerging Communicable Diseases --- Re-Emerging Infectious Disease --- Re-Emerging Infectious Diseases --- Reemerging Communicable Disease --- Reemerging Communicable Diseases --- Reemerging Infectious Disease --- Reemerging Infectious Diseases --- Communicable Diseases, Imported --- Zoonoses --- Viral Diseases --- Viral Infections --- Virus Infections --- Disease, Viral --- Disease, Virus --- Diseases, Viral --- Diseases, Virus --- Infection, Viral --- Infection, Virus --- Infections, Viral --- Infections, Virus --- Viral Disease --- Viral Infection --- Virus Disease --- Virus Infection