San Francisco, California
London, United Kingdom
MN ASQ Biomedical Consortium Presents:
ISO 13485:2016 Risk Based Approach
Overview: Due to overwhelming response to the first class on the new edition of the standard, we are providing another session for this update on the Quality Management System standard. This updated session will provide the detailed information of the changes published in March for adoption by companies before March of 2019. In addition, Mark Swanson will provide more detailed information on the Medical Device Single Audit Program (MDSAP) and the implementation and evidence your organization will need to provide for the risk based approach required for this edition.
When: Wednesday, December 7, 2016 (8:00 am - 4:00 pm) – (Check-In/Continental Breakfast begins at 7:30 AM)
Where: Doubletree – Park Place Hotel
1500 Park Place Boulevard
St. Louis Park, MN 55416
Who Should Attend: Engineers, Management, and other Employees responsible for Quality, Reliability, Regulatory, Production, and Development at Medical Device Manufacturers. Suppliers, Contract Manufacturers, and persons interested in the Biomedical Industry will also find this workshop valuable.
Cost: -Minnesota ASQ Member - $225
-ASQ Enterprise Member- $225
-Non-Member - $250
Continental Breakfast, Lunch, and Break Snacks are included.
Certificates of Completion: Issued on workshop completion for 0.7 ASQ RUs or 0.7 CEUs.
Instructors Bio: Mark Swanson's career spans more than 16 years in medical device quality, quality management systems and regulatory compliance. Mark has recently joined Regulatory and Quality Solutions (R&Q) as the Director for Minnesota operations for regulatory and quality consulting in the medical device industry. The past four years, Mark has been the President and lead consultant of H&M Consulting Group; a group focused on helping small to mid-sized companies have the same regulatory and quality systems knowledge and expertise as the large medical device companies. Mark has also had several different roles in medical device quality and regulatory at Medtronic and St. Jude. Mark is a Senior Member of ASQ and holds ASQ certifications as a Certified Biomedical Auditor (CBA), Certified Quality Engineer (CQE) and Certified Manager of Quality/Organizational Excellence (CMQ/OE).
Mark is an active member of ISO Technical Committee 210 (TC210) that recently published the third edition of ISO 13485 in March of 2016. He has also participated with ISO TC176 on the 2015 editions of both ISO 9001 and ISO 9000. He currently is the project co-lead for the development of the ISO guidance document for ISO 13485:2016 and the ISO Ad Hoc Group on post-market surveillance for medical devices. The work with ISO includes discussions regarding ISO 14971, the European Medical Device Regulation and other international standards and regulations for medical devices, including work on the Medical Device Single Audit Program (MDSAP) by the International Medical Device Regulators Forum (IMDRF).