RAPS Texas Chapter: ISO 13485:2016 Update – An Overview of the Changes

RAPS Texas Chapter: ISO 13485:2016 Update – An Overview of the Changes presented by Susan Mecca, technical manager of medical devices for LRQA in North America.

Thursday, July 28, 2016, 6-8 pm
Location: Austin, TX

Join your regulatory colleagues from across Texas for an evening of networking and an expert presentation on ISO 13485:2016. This meeting is sponsored by the RAPS Texas Chapter and is intended to promote knowledge advancement and facilitate networking among local regulatory and quality professionals. 

This session will cover the key changes from ISO 13485:2003 to ISO 13485:2016 and will help organizations better understand the differences between the old and new standard and how to address possible shortfalls.

Areas of focus will include:

  • Risk management
  • Design and development
  • Purchasing and suppliers
  • Production and service provision/validation

The presentation will provide answers to frequently asked questions, including:

  • What are some changes in the new standard that may not have been considered in the past?
  • What are the biggest obstacles?
  • What are some of the implications for suppliers to manufacturers under the new standard? 
For more information on the event click here