Safety Risk Management for Medical Devices by Bijan Elahi, demystifies risk management, providing clarity of thought and confidence to the practitioners of risk management as they do their work. Written with practicing engineers, safety management professionals, and students in mind, this book will help readers tackle the difficult questions, such as how to define risk acceptance criteria and how to determine when to stop risk reduction.
Medical Device Risk Management Course
Presented by Bijan Elahi MSEE, BS AeroE
Medical Devices Risk Management (MDRM) is a progressively more prominent topic in the medical device industry. Expectations by Regulatory bodies of medical device companies in producing quality, logical and defensible risk management files is rising. It is incumbent on the medical device manufacturers to convince the regulatory bodies that the benefits of a medical device outweigh its risks. Convincing the regulatory bodies is especially difficult for complex medical devices.
MDRM is a disciplined systematic approach to the analysis, estimation, evaluation, and control of safety risks associated with medical devices. Application of formal MDRM techniques can predict and prevent serious harm to patients and losses to businesses.
This 3-day training course delivered worldwide provides a comprehensive coverage of topics that are needed for successful management of safety risks of medical devices in conformance with the international standard ISO 14971. The scope of risk management includes both product development, and post market risk management.