Thursday, May 18, 2017
- 11 Gordon Collins Drive
- Gormley, Ontario, Canada L0H 1G0
- Current guidance around Medical Electrical Equipment for FDA 510(K) & HEALTH CANADA
- IEC 60601-1 series:
- 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
- ISO 14971:2007 Risk Management File (RMF) Overview
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- Leo Eisner
- Principal Medical Device Product Safety & Regulatory Consultant
- Eisner Safety Consultants
Leo’s firm specializes in helping medical device manufacturers through product safety, international regu-latory and quality system processes. He has been called the “IEC 60601-1 Guy” by his clients and asso-ciates. Leo’s focus is on active medical electrical equipment including home use and wearable de-vices. 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
- 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 eval-uated over 400 medical and laboratory projects and given various of seminars on regulatory and standards compliance.
9:00 AM - Meet & greet
9:15 AM - Introduction to TÜV SÜD Canada & presenter backgrounds
9:30 AM - 10:45 AM - Current US & Canadian guidance for medical electrical equipment
10:45 AM - Break
11:00 AM - 12:00 PM - Intro to IEC 60601-1 series
12:00 PM - 12:15 PM - Q&A
12:15 PM - 1:30 PM - Lunch / lab tour & test demo
1:30 PM - 2:30 PM - Design & compliance to 60601-1 3rd edition
2:30 PM - 3:30 PM - Upcoming standards changes & updates related to 60601 Series
3:30 PM - Break
3:45 PM - 4:45 PM - ISO 14971:2007 Risk management file (RMF) overview / QA