Sessions
ISO 14971:2019 - Overview and Applicability to EU MDR and other regions
11:50 AM - 1:00 PM Mon
Definitions and other elements introduced having impact to Process
1:30 PM - 2:15 PM Mon
Common Misconceptions & Wrap up for the day
3:30 PM - 4:00 PM Mon
Post Market Surveillance Planning
12:05 PM - 12:50 PM Tue
Tying it all together - EU MDR/Risk Management/Post Market Surveillance
2:45 PM - 3:30 PM Tue
Q&A & Wrap-up
3:30 PM - 4:00 PM Tue
During his 36-year career in medical devices, Mr. Bills has held a number of quality and regulatory affairs positions for major medical device companies, including a period as Corporate Director of Risk Management. He consults and provides training in the area of medical device risk management. With Stan Mastrangelo, he co-authored Lifecycle Risk Management for Healthcare Products: From Research Through Disposal published by PDA. ASQ has awarded Mr. Bills with Fellow status as well as Certified Quality Engineer, Certified Quality Auditor, Certified Manager of Quality and Organizational Excellence, and he is a Regulatory Affairs Certified by the Regulatory Affairs Professionals Society. Mr. Bills serves on the ISO technical committee that created the third edition of ISO 14971 risk management standard. He also serves on the AAMI technical committee CP, developing a combination products risk management guidance.