TMCnet News
Implementing ISO 134852016 Workshop - Morrisville, United States - April 27-28, 2017 - Research and MarketsResearch and Markets has announced the addition of the "Implementing ISO 134852016" conference to their offering. The final version of ISO 13485:2016 is now available and companies should be planning their implementation. There are significant changes from the earlier version; they will require major modifications to the Quality Management System (QMS). The new version has better alignment with FDA's QSR, but there are still major differences that create issues for effective QMS implementation. This workshop covers the differences from the 2003 version to the 2016 version and offers practical implementation advice to update your QMS. Participants will also learn the differences with QSR and understand how to resolve them. The workshp uses extensive examples and exercises to help clarify the concerns. Some regulatory systems will rely on ISO 13485:2016 through the Medical Device Single Audit Program (MDSAP). The US will participate in MDSAP, but doesn't expect to change its regulations. The EU is not participating, has published its own version, EN ISO 13485:2016, and will continue with the Notified Body system. However, the EU intends to replace the directives with new regulations resulting in new versions of EN ISO 13485:2016 and EN ISO 14971:2012. Agenda: Day 1 Schedule Lecture 1: Overview of ISO 13485:2016 Lecture 2: Regulatory Framework Lecture 3: Management Responsibility Lecture 4: Resource Management Lecture 5: Design and Development Day 2 Schedule Lecture 1: Supplier Management Lecture 2: Production Processes Lecture 3: Process Validation Lecture 4: Monitoring and Measuring Lecture 5: Corrective and Preventive Action For more information about this conference visit http://www.researchandmarkets.com/research/kzgfkg/implementing_iso
View source version on businesswire.com: http://www.businesswire.com/news/home/20161207006125/en/ |
