On Wednesday - August 16th 2017, Deborah Stubbs, Staff Engineer, Lead Auditor, UL and Michael Windler, Global Regulatory Manager, UL presented a live webinar on Canada's 2019 transition from CMDCAS to MDSAP. The Medical Devices Single Audit Program (MDSAP) was created by the International Medical Device Regulators Forum (IMDRF) to allow manufacturers to meet the quality management system (QMS) for participating countries with a single QMS audit. The MDSAP gives manufacturers the opportunity to meet Quality System requirements for major markets including the USA, Canada, Australia, Japan and Brazil, all in a single audit! Out of these countries, Canada has already announced it will replace its CMDCAS program with the MDSAP on January 1, 2019. If you have sales in Canada, it’s critical you understand the effect on your business.
The 30-minute recording of this event is now available. In the recording, Deborah Stubbs and Michael Windler addresses the key items on MDSAP implementation, process overview, country specific requirements etc.
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Within the UL family of companies we provide a broad portfolio of offerings to all the medical device industries. This includes certification, Notified Body and consultancy services. In order to protect and prevent any conflict of interest, perception of conflict of interest and protection of both our brand and our customers brands, UL is unable to provide consultancy services to Notified Body or MDSAP customers. UL has processes in place to identify and manage any potential conflicts of interest and maintain impartiality. Read more about this.