The new ISO 13485 revision is finally here and, for medical device manufacturers, this is big news. You probably have plenty of questions about how the new standard will affect yoru company: do I have to completely overhaul my QMS? When do I have to comply?
ISO 13485:2016 provides an international standard that can be truly harmonized across multiple regions and regulatory requirements. But it also introduces notable QMS changes, particularly in the area of risk management. In this 16-page white paper, we answer your biggest questions about ISO 13485:2016, including:
- Overview of the update to the new standard
- Breakdown of what has changed in each section
- Guidelines on how to prepare for the new standard
- Deadline for recertification
- Requirements for recertification
- Considerations for timing the update and recertfication
Learn all this and more in this white paper.
About the Author:
Richard Vincins, CBA, CQA, RAC (US/EU): Richard Vincins is Vice President, Quality Assurance Consulting at Emergo. With over 25 years of experience in the medical device industry, Richard's areas of expertise include ISO 13485, US FDA QSR, and many other country quality system implementations including Canada, Japan, Brazil. Additional areas of expertise include US FD A 510(k) registration, European CE Marking, multiple country product registrations, risk management, and clinical investigations. Richard’s main focus and responsibilities are advising compliance of medical device and IVD companies to the ever expanding regulatory requirements.