Systems engineering training and consulting
Portuguese Chinese

Medical Device Risk Management

A course presented over 5 half days (2.5 days total) by Bijan Elahi

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 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.