When: 30 November 2021 | 12:30 GMT
This webinar provides an overview of the regulatory and licensing requirements for medical devices in Canada including classification rules, licensing and regulatory authorization pathways, quality system requirements, performance testing, clinical trials, and post-market requirements.
During this webinar, delegates will gain an understanding of the Canadian medical device regulatory landscape including:
- Medical device classification rules
- The types of licences and regulatory authorization pathways
- Quality system requirements
- Safety and effectiveness requirements
- How clinical trials are regulated
- Post market requirements for manufacturers, importers and distributors
This webinar is suitable for those with between 2-5 years’ experience in medical devices regulatory affairs.
Sarah Bassler is a senior partner at PASB Technical Solutions Inc., a Canadian engineering consulting firm providing engineering, regulatory and quality consulting support to the global medical devices industry.
A chemical engineer by training, Sarah worked for over 15 years as a regulator in North America and Europe before joining PASB where she helps medical device manufacturers, importers and distributors from start-ups to established companies understand and comply with Canadian, U.S., and European market authorization requirements. Sarah’s areas of specialization include regulatory strategy, quality systems, performance testing, and regulatory submissions.
Sarah has a Bachelor of Engineering from McMaster University and a Master of Applied Science from the University of Waterloo. During her free time, you will find Sarah hiking and camping with her family.
This course offers 1.5 CPD hours for successful completion. To learn why CPD is important visit our Lifelong Learning page.
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