In this 20 minute webcast, Susan Mecca, Senior Technical Manager, Medical Devices - LRQA Americas, will provide practical guidance and real-world application and implementation of some of the new additions and revisions in ISO 13485:2016, particularly those around Risk Management and the Interconnection with other Regulatory Requirements to the corresponding Medical Device Directives (MDD) and In Vitro Diagnostic Medical Devices (IVDD).
Some of the topics Susan will cover include:
- What’s new to ISO 13485:2016 and what has changed from ISO 13485:2003
- ISO 13485:2016 vs ISO 9001:2008 and ISO 13485:2016 vs ISO 9001:2015
- ISO 13485:2016 certification timeline
This webcast will help manufacturers and consulting organizations better understand the differences between the old and new standard and how to address possible shortfalls, particularly in the areas of risk.