ISO 13485:2016 (3rd Edition)

The ISO 13485:2016 specifies requirements for a QMS that can be used by an organization involved in one or more stages of the life-cycle of a medical device, including design and development, production, storage and distribution, installation, servicing and final decommissioning and disposal of medical devices, and / or associated activities.

Several jurisdictions also have regulatory requirements for the application of QMS by organizations with a variety of roles in the supply chain for medical devices. This brief presentation will explain some of the changes between the ISO 13485:2003 (2nd Ed) and the ISO 13485:2016 (3rd Ed).

Speaker : Abe Wong

Abe Wong has been an active ASQ member for 20 years with almost 1/2 of the time serving the ASQ-San Diego chapter as their Programs Chair before relocating to Seattle. Abe has worked over 20 years in the FDA regulated industries including medical device, pharmaceutical, food supplement, and cosmetics. Besides certified as a FDA Clinical Investigator, he is also an ISO 13485:2016 Certified Auditor, an ASQ-CQA and a Certified Lean Six-sigma Master Black Belt.

Date: Thursday November 10, 2016
Time: 5:00 pm – 8:00 pm
Coast Bellevue Hotel
625 116th Ave. NE
Bellevue, WA 98004
(425) 455-9444