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CMDCAS
Certification and the Canadian MDR
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This webinar provides an overview of the Canadian Medical Devices Regulations (CMDR) and explains the process for CMDCAS Certification. Our speaker identifies each of the unique requirements that differentiate CMDCAS from standard ISO 13485 certification. He also provides advice on how to organize your technical documentation to simultaneously meet the requirements of Health Canada and the future European Medical Device Regulations.
Topics include:
- Organization of the CMDR
- Mandatory Problem Reporting
- Recalls
- Distribution Records
- Medical Device Licenses
- Establishment Licenses
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presenter
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Rob Packard, Medical Device Academy, Inc.
The speaker has 20+ years experience in the medical device, pharmaceutical and biotechnology industries. He is a graduate of UConn in Chemical Engineering with Quality Management System expertise covering all aspects of developing, training, implementing and maintaining compliance with ISO 13485 and ISO 14971. From 2009-2012, he was a lead auditor and instructor for a Notified Body. Rob’s specialty is regulatory submissions of high-risk medical devices for CE marking, Canadian medical device applications and 510(k) submissions. He founded the Medical Device Academy in 2012 as a consulting firm focused on helping medical device companies with regulatory submissions and quality system implementation. The most favorite part of his job is training others.
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Ron. M Mathis
Mr. Mathis is SGS’s VP, Healthcare. In this role, he’s responsible for the leadership of the Healthcare section, including Medical Device Certification and Training, as well as the delivery of auditing service within the Pharma and Cosmetics Industry for SGS in North America. An industry veteran with many years of experience in Management Systems, Ron’s experience include leadership roles in other certification Bodies.
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