DUBLIN--(BUSINESS WIRE)--Research and Markets has announced the addition of the "ISO 13485 2016-Quality management systems - Requirements for regulatory purposes - Webinar" webinar to their offering.

In this free webinar, see how audit readiness can be strengthened as the FDA transitions from QSIT to QMSR. Attendees will learn about the implications of the shift from inspection-based QSIT to a ...

Overview: ISO 13485:2003 is a quality management system standard specially written for the medical device industry and is on the U S Food & Drug Administration (FDA) list of recognized consensus ...

TAMPA, FLa.--(BUSINESS WIRE)--Pilgrim Quality Solutions, a leading global provider of enterprise quality management software and services for the Life Sciences, today announced it will present a live ...

For laboratories that operate within a quality management system, compliance with global standards such as ISO 9001, ISO 13485, ISO 17025, ISO 15189, GxP, and other country-specific regulations ...

Details:This presentation will provide an understanding of the current expectations of ISO 13485 notified body auditors regarding containment or correction of a nonconformity. There will be a review ...

For years, the medical device industry has been expecting the alignment of FDA’s 21 CFR Part 820 quality system regulation (QSR) with the international ISO 13485 standard. FDA issued a proposed rule ...