May 9, 2020 | Risk Management
Forward: This second article in our series addresses a common risk analysis problem: prioritization. In large medical device companies, the email invitation to an FMEA session can strike fear (or at least dread) into the hearts of engineers and other members of the...
May 3, 2020 | Risk Management
Forward: MEDIcept is presenting this paper as an introduction to an ongoing series of articles focused on the conduct of risk management in the medical device and invitro diagnostic industry. The intent of the series is to provide practitioners with insight into how...
Dec 23, 2019 | Risk Management, Documents, News
In 2000, the first edition of ISO 14971 was released as the international standard for risk management of medical devices. This year, the ISO technical committee (ISO/TC 210) has been hard at work updating this globally-recognized standard. And while the fundamental...