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3-Day Training Event on PPE Standards; Nov 29th, Nov 30th and Dec 1st, 2021
•Day 1 Topics - Nov 29th 2021
○ US market requirements (product specification, packaging, labeling, etc.) - gowns, masks and surgical drapes
○ Applicable International Standards for US Regulations - gowns, masks and surgical drapes
○ US FDA 510k and process to get certification
○ Requirement for obtaining FDA approval – gowns, masks and surgical drapes

•Day 2 Topics - Nov 30th 2021
○ EU /UK market requirements (product specification, packaging, labeling, etc.) - gowns, masks and surgical drapes
○ Applicable International Standards for EU & UK Regulations - gowns, masks and surgical drapes
○ Requirement for obtaining CE marking approval – gowns, masks and surgical drapes

•Day 3 Topics - Dec 1st 2021
○ General requirements for quality management system – medical devices ISO 13485:2016 with focus on real life implementation challenges.
Dec 1, 2021 01:30 PM
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Speakers

Michael Wetherington
Michael Wetherington is an RA/QA and medical device engineering consultant to Testing Partners. Over the past 25 plus years, Michael has worked work for major accredited testing laboratories and notified bodies certifying medical devices. His medical device experience include both non-active and active devices ranging from joint compression devices, surgical saws to rapid infusion pumps. Michael has also worked for medical device R&D companies. He is currently a mentor in Elemed's Mentoring Program where he donates his time mentoring RA/QA professionals achieve their goals and develop their leadership skills. He is currently working on several projects involving regulatory assessments for the US FDA, EU MDR, and UK. His overall medical device regulatory experience span across multiple markets to include, US FDA 510k, CE marking under the MDR, UKCA marking, ASEAN Medical Device Directive, to name a few.
Han Zuyderwijk
Han Zuyderwijk is a Senior Regulatory and Product Compliance Consultant for Testing Partners, specialized in European Union technical regulations and CE marking certification. Since 1995, he has assisted more than a thousand companies of all sizes to get CE marking for their products, including also manufacturers of face masks, gowns, and protective gloves. Han also has worked as a trusted expert in numerous legislative projects, helping governments of many countries to prepare legislation implementing new regulatory systems for products in their country. This helps him to thoroughly understand the regulations and their effect on businesses and processes.