ISO 13485:2016 – Changes and Requirements
Published on March 1, 2016, ISO 13485:2016 updates the international medical devices quality management systems standard. Join our webinar to learn about the changes and the impact they will have on manufacturers.
15 Dec 2016, 03:12
01 Jan 2017, 00:00
As part of its service of keeping manufacturers up to date with changes in the regulatory framework, SGS is holding this webinar on ISO 13485:2016, the new revision to ISO 13485, which was published on March 1, 2016.
This 1 hour (45 minute presentation/15 minute Q&A) complimentary webinar will cover the changes and new themes found in this update to ISO 13485. The webinar aims to provide a high level overview of the changes made to the standard with the publication of ISO 13485:2016, on March 1, 2016, and their effect on manufacturers.
- Overview of key changes and developments for ISO 13485:2016, including changes to quality management systems
- Structure and terminology for the new ISO 13485 update
- Next steps for getting certified to ISO 13485:2016
Dr. Andrew Norrish, Technical Manager, Global Medical Devices
Andrew is responsible for providing technical support for SGS’s global medical device activities. He has more than 12 years experience in the medical device industry and previously held quality and regulatory roles in medical device and in vitro diagnostic (IVD) manufacturing. Prior to working with medical devices, Andrew worked in pharmaceutical operations within active pharmaceutical ingredient (API) manufacturing.
The webinar presentation will also be supported by: Mr. Kevin Butcher, Operations Manager, Global Medical Devices
For more information, please contact:
SGS Hong Kong
Tel: (852) 2765 3620
SGS is the world’s leading inspection, verification, testing and certification company. SGS is recognized as the global benchmark for quality and integrity. With more than 85,000 employees, SGS operates a network of over 1,800 offices and laboratories around the world.