Dates: February 17–19, 2021 from 8:00 a.m. to 5:00 p.m. ET
This comprehensive three-day course for medical device manufacturers presents risk management concepts used throughout the quality system that can help your organization meet FDA and ANSI/AAMI/ISO 13485:2016 requirements for risk management. This course covers the use of risk management principles throughout the lifecycle of the product (design, manufacturing, post-production, retirement). Instructors will illustrate linkages between the product risk management process and quality system processes. Students will discover how to use regulatory databases to support risk management activities at different stages of the product lifecycle, as well as the use of International Product Safety Standards during risk management activities.
Join us to...
- Understand risk management concepts used throughout the quality system to successful meet FDA, ANSI/AAMI/ISO 14971, and ANSI/AAMI/ISO 13485:2016 requirements.
- Learn how to use risk management to make risk-based decisions for product realization, from cradle to grave.
Meet the Faculty
Edwin L. Bills
Edwin Bills, Consultant
Nicola Martin BSc., H.Dip
Lisheen, Moyvilla, Oranmore, Co.
Virtual Training Information
Our virtual training environment allows you to have direct interaction with your instructors and your fellow attendees. AAMI uses Zoom for virtual classes. You can test your connectivity and ability to use Zoom at zoom.us/test.
For virtual training courses, we request that you register at least one week in advance of the course start date to allow sufficient time for shipping of training materials and devices (Please allow two weeks for non-U.S. addresses). If you register within these time frames, AAMI cannot guarantee you will receive material prior to the start of the course but you will have access to digital versions of the materials. If you have any questions, please email email@example.com.
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Principal Consultant, Edwin Bills, Consultant
During his 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 has over 36 years’ experience in the field of quality and regulatory affairs, including time as Director of Quality and Regulatory concurrently for four US sites. Currently he consults and provides training in the area of medical device quality, regulatory and risk management. With Stan Mastrangelo, he co-authored Lifecycle Risk Management for Healthcare Products: From Research Through Disposal published by PDA. Mr. Bills was also a member of the adjunct faculty serving Virginia Tech’s graduate on-line degree program in Health Products Risk Management. 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. Additionally, Mr. Bills serves in international standards work, assisted in completing the revision of the third edition of ISO 14971 risk management standard as an international member of the technical committee. He also serves on the US national committee for the medical devices quality system standard, ISO 13485, as well as the medical bed standard, IEC 60601-2-52, and the AAMI technical committee CP, developing a combination products risk management guidance. .
Quality Assurance - Lisheen, Moyvilla, Oranmore, Co.
Nicola Martin has been working in the Medical Device Industry for over 15 years and most recently was working as the Associate Director for International Quality and Compliance in Medtronic formally Covidien. In this role herresponsibilities included managing the Corporate Audit program, creating and delivering Corporate Audit training programs as well as external audit preparation. Prior to this role she also worked for Boston Scientific as well a number of smaller Medical Device companies. Her responsibilities have included Supplier Quality, Internal Auditing, New Product Introduction, Process Control and Development as well as ISO and QSR compliance.Ms. Martin holds a BSc. degree in Science specializing in Chemistry. She also has a higher diploma in Quality Assurance and is currently working to option a Master's degree in Operations and Quality Management/Applied Science.