Archive for March 30th, 2018

ISO 13485:2016 rewrites the standard for medical device manufacturing

A risk-based approach to QMS. If you’re a manufacturer of medical devices, including the medical device portion of combination products this is not the first time you’ve encountered this emphasis; the shift towards Quality by Design (QbD) has placed risk assessment and management at the forefront of compliance and regulatory considerations for organizations operating within the life sciences industries. But ISO 13485:2016 and its quickly approaching requirements for certification have brought risk front and center for medical device manufacturers with a renewed urgency. Read more »