MEDICAL COMPLIANCE SEMINAR
Thursday, May 18, 2017
Seminar Topics:
- Current guidance around Medical Electrical Equipment for FDA 510(k)s & Health Canada
- IEC 60601-1 series:
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- Intro to IEC 60601 -1 series with Collateral & Particular Standards
- Design & compliance to IEC 60601-1 3rd edition (including AM1)
- Changes to the 60601-1 series and supporting standards: Updates on what’s new and draft documents that may impact your Compliance strategy
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- ISO 14971:2007 Risk Management File (RMF) Overview
See the detailed Seminar Agenda.
Sign-up for Workshop Closed
Bio’s of Presenters
Leo Eisner, principal medical device product safety & regulatory consultant of Eisner Safety Consultants.
Leo’s firm specializes in helping medical device manufacturers through product safety, international regulatory and quality system processes. He has been called the “IEC 60601-1 Guy” by his clients and associates. Leo’s focus is on active medical electrical equipment including home use and wearable devices. Leo is the US co-chair of IEC SC62D (majority of IEC 60601-2-xx standards), convener of IEC SC62D JWG9 (IEC/ISO80601-2-58) & a committee member of US TAG for TC62, SC62A, SC62D, & SyC AAL (Active Assisted Living System Committee – Home use medical and non-medical devices). Leo is a registered professional engineer in safety and has over 30 years experience in product safety. Leo is a member of RAPS, AAMI, ASQ, & IEEE. He’s manager of the LinkedIn discussion group IEC 60601 Series – Medical Electrical Equipment.
Peter Keith P.Eng, Senior Engineer and Technical Certifier at TÜV SÜD Canada Inc.
Peter is the lead medical services engineer at TÜV SÜD Canada with 10 + years of safety evaluation and regulatory experience, specializing in safety certification of medical and laboratory equipment such as hospital beds, ECGs, therapeutic lights, TENS, Lasers and more. Peter has participated on technical committees such as CACES (Canadian Advisory Committee on Electrical Safety) and assisted on the development of CSA SPE – 3000:2015. Peter is a licensed professional Engineer in Ontario and has evaluated over 400 medical and laboratory projects and given various seminars on regulatory and standards compliance.
Meet and Greet (9:00 AM)
Introduction to TÜV SÜD Canada & Presenter’s Backgrounds (9:15 AM)
Current US & Canadian Guidance for Medical Electrical Equipment
(9:30 to 10:45 AM)
Break time (15 Minutes)
Intro to IEC 60601-1 series (11:00 to 12:00 PM)
Q & A for Morning Session (12:00 – 12:15 PM)
Break for Lunch (lab tour and test demo) (12:15 to 1:30 PM)
Design and Compliance to 60601 – 1 3rd edition (1:30 to 2:30 PM)
Upcoming Standards Changes and Updates Related to 60601 Series
(2:30 to 3:30 PM)
Break time (15 Minutes)
ISO 14971:2007 Risk Management File (RMF) Overview (3:45 – 4:45 PM)
Q & A