Safety Risk Management For Medical Devices

Safety Risk Management for Medical Devices by Bijan Elahi Pdf

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

Mastering Safety Risk Management for Medical and In Vitro Devices by Jayet Moon,Arun Mathew Pdf

When it comes to medical and in vitro devices, risk management starts with a design assurance process that helps practitioners identify, understand, analyze, and mitigate the risks of the healthcare product design for favorable benefit-risk assessment. Risk management actively follows the product’s life cycle into production and post-market phases. This book offers a blueprint for implementing an effective risk management system. It provides risk management tools and a compliance framework for methods in conformance to ISO 13485:2016, ISO 14971:2019, European Union MDR, IVDR, and US FDA regulations (including the new FDA QMSR).

Medical Devices. Application of Risk Management to Medical Devices by British Standards Institute Staff Pdf

Medical equipment, Medical instruments, Risk assessment, Risk analysis, Management, Hazards, Clinical investigation instruments, Safety measures

Safety of Electromedical Devices by Norbert Leitgeb Pdf

Preface Development in the feld of medical technology has resulted in a manifold of medical devices enabling us to diagnose illnesses more reliably, treat them more effciently and compensate for handicaps more effectively. However, these improvements are also - sociated with safety risks. Today, patients are in contact with an increasing number of medical devices longer and more intensively then before. Applied parts are put into contact with the body, probes may be introduced into the body via natural or surgical orifces, and even whole devices may be implanted for many years. The application of devices is no longer restricted to medical locations only. Home use by lay people is increasing and involves even critical devices such as for dialysis, nerve and muscle stimulation and ventilation. In contrast to users’ patients are in a special situation. Their life could depend on the performance of a device, they might be unconscious, may have impaired reactions, or have been made insensitive to pain by medication, and hence they may be exposed to hazards without their awareness and protection by their own reaction. Therefore, medical devices must meet particularly stringent safety requirements. However, the question arises how safe is safe enough? The readiness to accept risks depends on a variety of accompanying circumstances. In fact, subjective risk p- ception varies among individuals and differs from country to country, and frequently only in rare cases it is in agreement with assessments of objective scientifc ana- ses.

Managing the Risks from Medical Product Use by United States. Food and Drug Administration. Task Force on Risk Management Pdf

Risk Management of Medical Devices for Healthcare Organisations by James Mccaley Pdf

Covers designing and structuring a surveillance system to monitor medical devices Reviews current and future techniques to oversee, track, and assess medical devices within a healthcare organization Covers designing and structuring a surveillance system to monitor medical devices in order to help you comply with reforms on post market device surveillance Discusses all aspects of risk management in medical device development from ideation to application Risk Management of Medical Devices for Healthcare Organizations will help you identify what risks exist with medical devices in the context of a healthcare organization. The contents include coverage of how firms currently manage such risks (active vs. passive device surveillance), the strengths and limitations of those methods and what new directions the industry is heading to in order to optimize risk management. James McCauley has developed this book with a global audience in mind, and has prepared a comprehensive table of contents covering all aspects of risk management. This book is ideal for anyone at management level who needs to implement a risk management system for medical devices within a healthcare organization. McCauley includes information about automated reporting and analysis systems such as FAERS and DELTA systems, plus coverage of the medical device identification system US UDI. If you are researching and developing methods to survey and assess medical device safety and performance, this book will help you to generate a sound foundation in current methods for risk management of medical devices to pioneer new research. For clinical engineers, this book will help you to prevent and resolve equipment failure and any potential complications. About the author James McCauley Manager, Clinical Technology Services, Central Coast Local Health District Biomedical Engineer at Open Heart International Managing Director, M Engineering Australia Pty Ltd, trading as James McCauley & Associates

James McCauley has over 30 years of experience working in healthcare and biomedical engineering, specifically with a clinical engineering focus. At Open Heart International he supports open heart surgical teams on outreach missions and other medical specialties in developing countries. As a manager at Clinical Technology Services he is responsible for the implementation of Point of Care IVD’s, including evaluation and clinical assessment. He is also the current chairman for Biomedical Engineering Management Group NSW. James consultants for various commercial clients including Seventh Day Adventist Hospital, Medtek Pty Ltd, and the Commonwealth of Australia, represented by the Therapeutic Goods Administration. Until 2012 he was the Head of Biomedical Engineering at Royal Alexandra Hospital for Children, where he was responsible for research into and development of medical devices. He is currently the chair of the Biomedical Engineering Management Group NSW (BMEG) which represents the NSW Government, the NSW Public Health System and all 135 public hospitals in NSW.

DESIGN CONTROLS, RISK MANAGEMENT & PROCESS VALIDATION FOR MEDICAL DEVICE PROFESSIONALS by Vernon Geckler Pdf

This handbook provides the most up to date resource currently available for interpreting and understanding design controls. This handbook is the most exhaustive resource ever written about FDA & ISO 13485 design controls for medical devices with a collection of all applicable regulations and real-world examples. Four-hundred & forty, 8.5" X 11" pages provides an extensive evaluation of FDA 21 CFR 820 and is cross-referenced with ISO 13485 to provide readers with a broad and in-depth review of practical design control implementation techniques. This handbook also covers basic, intermediate and advanced design control topics and is an ideal resource for implementing new design control processes or upgrading an existing process into medical device quality systems. This critical resource also specifically outlines key topics which will allow quality managers and medical device developers to improve compliance quickly to pass internal and external audits and FDA inspections. The author breaks down the regulation line by line and provides a detailed interpretation by using supportive evidence from the FDA design control guidance and the quality systems preamble. Numerous examples, case studies, best practices, 70+ figures and 45+ tables provide practical implementation techniques which are based on the author's extensive experience launching numerous medical device products and by integrating industry consultant expertise. In addition, bonus chapters include: explanation of medical device classification, compliance to design controls, risk management, and the design control quality system preamble. 20-40 pages are dedicated to each of the major design control topics: Design and Development Planning, Design Input, Design Output, Design Transfer, Design Verification, Design Validation, Design Change and Design History File.

RISK MANAGEMENT FOR THE MEDICAL DEVICE INDUSTRY by Dr. Akash Sharma, Ms. Vriti Gamta , Mr. Gaurav Luthra Pdf

"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.

Integrated Safety and Risk Assessment for Medical Devices and Combination Products by Shayne C. Gad Pdf

While the safety assessment (“biocompatibility”) of medical devices has been focused on issues of local tissue tolerance (irritation, sensitization, cytotoxicity) and selected quantal effects (genotoxicity and acute lethality) since first being regulated in the late 1950s, this has changed as devices assumed a much more important role in healthcare and became more complex in both composition and in their design and operation. Add to this that devices now frequently serve as delivery systems for drugs, and that drugs may be combined with devices to improve device performance, and the problems of ensuring patient safety with devices has become significantly more complex. A part of this, requirements for ensuring safety (once based on use of previously acceptable materials – largely polymers and metals) have come to requiring determining which chemical entities are potentially released from a device into patients (and how much is released). Then an appropriate and relevant (yet also conservative) risk assessment must be performed for each identified chemical structure. The challenges inherent in meeting the current requirements are multifold, and this text seeks to identify, understand, and solve all of them. • Identify and verify the most appropriate available data. • As in most cases such data is for a different route of exposure, transform it for use in assessing exposure by the route of interest. • As the duration (and rate) of exposure to moieties released from a device are most frequently different (longer) than what available data speaks to, transformation across tissue is required. • As innate and adaptive immune responses are a central part of device/patient interaction, assessing potential risks on this basis are required. • Incorporating assessments for special populations such as neonates. • Use of (Q)SAR (Quantitative Structure Activity Relationships) modeling in assessments. • Performance and presentation of integrative assessments covering all potential biologic risks. Appendices will contain summarized available biocompatibility data for commonly used device materials (polymers and metals) and safety assessments on the frequently seen moieties in extractions from devices.

Medical Devices by Canadian Standards Association,International Organization for Standardization,Standards Council of Canada Pdf

Design Control, Medical Device Risk and Medical Device Regulation (MDR 2017/745) by Des O'Brien Pdf

This short book is a starting point to introduce Design control, risk management and regulatory impact and application of Medical Device Directive MDR 2017/745 or to give its full name- Regulation (Eu) 2017/745 Of The European Parliament And Of The Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC.The importance of design controls manifests itself in the potential impact of device quality and safety for the public or patient in need of medical devices or therapeutic devices. The benefits of well executed design controls support a device and product development lifecycle that ensures the intended use is met and verified during the product development process and beyond. Best practice and compliant application of design controls depends on input definition, appropriate review of inputs and a continuous verification and validation to provide outputs. Design Control regulations ensure that good quality management (QM) practices are used for the design of medical devices and products remain fit for purpose and appropriate to the intended use. Adding to the design control requirements for manufacturers is the science of risk management applied to devices and products across the lifecycle of each product.Risk needs to be a continuous consideration and is not just a static or once off activity. The approach to risk must be suitable for the device in question. A Risk plan should lay out the approach, requirements and techniques used to assess risk and complete risk analysis. Any risks that remain must have a clinical benefit and must be managed ensuring residual risks are as low as possible. Therefore, an integrated approach to design, risk management and manufacturing creates a template for safe and effective products. Recent regulatory requirements that will shape the future of medical device regulation have gained increasing importance. Such regulation is the Medical device regulation prescribed by the European Union, MDR 2017/745 and associated amendments. These requirements shape the manner of an organizations management of risk and the safety of users. Any risk assessments depend on the design features of a device, and how well they are implemented, verified and validated. Only a well-planned and well-maintained quality management system, cognizant of regulation, design management and risk management will achieve compliance and success.

Managing Medical Devices within a Regulatory Framework by Beth Ann Fiedler Pdf

Managing Medical Devices within a Regulatory Framework helps administrators, designers, manufacturers, clinical engineers, and biomedical support staff to navigate worldwide regulation, carefully consider the parameters for medical equipment patient safety, anticipate problems with equipment, and efficiently manage medical device acquisition budgets throughout the total product life cycle. This contributed book contains perspectives from industry professionals and academics providing a comprehensive look at health technology management (HTM) best practices for medical records management, interoperability between and among devices outside of healthcare, and the dynamics of implementation of new devices. Various chapters advise on how to achieve patient confidentiality compliance for medical devices and their software, discuss legal issues surrounding device use in the hospital environment of care, the impact of device failures on patient safety, methods to advance skillsets for HTM professionals, and resources to assess digital technology. The authors bring forth relevant challenges and demonstrate how management can foster increased clinical and non-clinical collaboration to enhance patient outcomes and the bottom line by translating the regulatory impact on operational requirements.

Medical Device Safety by G.R Higson Pdf

Medical Device Safety: The Regulation of Medical Devices for Public Health and Safety examines the prospects for achieving global harmonization in medical device regulation and describes a possible future global system. Unresolved difficulties are discussed while solutions are proposed. An essential book for all those involved in health physics, en

Medical Device Regulations by Michael Cheng,World Health Organization Pdf

The term 'medical devices' covers a wide range of equipment essential for patient care at every level of the health service, whether at the bedside, at a health clinic or in a large specialised hospital. Yet many countries lack access to high-quality devices, particularly in developing countries where health technology assessments are rare and there is a lack of regulatory controls to prevent the use of substandard devices. This publication provides a guidance framework for countries wishing to create or modify their own regulatory systems for medical devices, based on best practice experience in other countries. Issues highlighted include: the need for harmonised regulations; and the adoption, where appropriate, of device approvals of advanced regulatory systems to avoid an unnecessary drain on scarce resources. These approaches allow emphasis to be placed on locally-assessed needs, including vendor and device registration, training and surveillance and information exchange systems.

Risk Management: ISO 14971 by Beverly White Pdf

Comprehensive yet concise reference edition to assist in the application of Risk management for medical devices. ISO 14971, is an established standard that is recognized worldwide by regulators. It is acknowledged as being the principal standard to use when performing Medical Device Risk Management. PART 1: RISK MANAGEMENT Introduction Basic terms and definitions General Requirements Regulations and Standards Regulation2017/745 (EU MDR) U.S. Food and Drug Administration (FDA) Health Canada Medicines and Healthcare products Regulatory Agency Japan MHLW Australian Therapeutic Goods Administration (TGA) ISO 13485 ISO 16142-1 2017/745 (EU MDR) & Risk Management GHTF & Risk Management Risk Analysis Reasonably foreseeable misuse Identification of characteristics related to safety Identification of hazards and hazardous situations Hazardous Situations Risk Analysis Techniques Preliminary Hazard Analysis (PHA) Fault Tree Analysis (FTA) Failure Mode and Effects Analysis (FMEA) Hazard Analysis and Critical Control Point (HACCP) Risk Estimation / Evaluation Probability Risk Estimation Risk Control Risk Acceptability Criteria for risk acceptability Evaluation of overall residual risk and acceptability Criteria for risk acceptability Role of Management Risk Management Plan Risk Management Plan inputs Risk Acceptability Method to evaluate overall residual risk Verifications methods and activities Post production and Post Marketing Requirements Risk Management Review and Reporting Severity Risk Management File Overall Residual Risk Benefit-risk analysis Criteria of benefit-risk analysis Residual Risk Post Production Review FMEA, Failure Mode and Effects Analysis Risk Management and Role of Standards ISO 16142-1 Essential Principles relating to Risk ISO/IEC Guide 63 IEC 62366-1 ISO 10993-1 ISO 14155 Usability Engineering and Medical Devices Product Realization Process and Risk Management PARRT II: FAILURE MODES AND EFFECTS ANALYSIS (FMEA AND FMECA) Introduction Why FMEA Methodology for FMEA Appendix 1 ANNEX I - General Safety And Performance Requirements Appendix 2 Regulation (EU) 2017/745 -Chapters and articles