PPI Company News

Read interesting stories relevant to Project Performance International milestones, people and events.

Safety Risk Management for Medical Devices





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.

Upcoming Courses:

Berlin, DE 17  – 19 Mar 2020 Register
Boston, MA 28 – 30 Apr 2020 Register
Los Angeles, CA 25 – 27 Aug 2020 Register
Eindhoven, NL 01 – 03 Dec 2020 Register


2023_PPI-Website_Side-bar-portrait_350x350px (2)


Your success matters to us. Acquire new skills to excel in 2024. Register your interest today!




FREE Monthly SE Industry News?

Why Recognition of Profit, not Imposition of Process, Will Ultimately Bring Systems Engineering Into Common Usage

What Factors Hold Back the Widespread Practice of Systems Engineering? Randall Iliff explores this fascinating question in the April 2023 issue of PPI SyEN. His perspective as a founding member of INCOSE and current PPI Principal Consultant offers unusual clarity regarding the challenges we face […]

Scroll to Top