Compliance with Canadian Quality Management System Regulatory Requirements

Instructor: Edward Kimmelman
Product ID: 704726
  • Duration: 90 Min
The training program will provide insight into complying with the key QMS requirements for organizations selling medical devices in Canada.

recorded version

1x Person - Unlimited viewing for 6 Months
(For multiple locations contact Customer Care)
Recorded Link and Ref. material will be available in My CO Section
Last Recorded Date: Jul-2016

Training CD / USB Drive

One CD/USB is for usage in one location only.
(For multiple locations contact Customer Care)
CD/USB and Ref. material will be shipped within 15 business days

Customer Care

Fax: +1-650-362-2367


Read Frequently Asked Questions

Why Should You Attend:

This webinar will examine the relationship between the Canadian quality management system (QMS) regulations and the requirements contained in ISO 13485:2003. It will also offer insight into handling the most common quality QMS problem areas and discuss the revisions contained in the 2016 version of the standard.

Areas Covered in the Webinar:

  • Relationship between the Canadian quality management system (QMS) regulations and the requirements contained in ISO 13485:2003.
  • Canadian QMS requirements in addition to the requirements contained in the standard (Refer: GD210: ISO 13485:2003 QMS Audits Performed by Health Canada Recognized Registrars).
  • Insight into handling the most common quality QMS problem areas.
  • A discussion of the revisions contained in the 2016 version of the standard.
  • The Canadian medical device quality management system regulatory requirements

Who Will Benefit:

  • Quality Professionals
  • Quality Audit Managers
  • Regulatory Professionals
  • Production Managers
  • Process Owners
  • Project Managers

Instructor Profile:

Edward Kimmelman has been providing consultant services in the areas of regulatory compliance and quality management systems since 1998. During a 35-year career in industry, he has served in engineering, product management, and senior quality systems management positions.

Mr. Kimmelman is a past president of the NCCLS (currently CLSI) and has served as chairman of the HIMA (currently AdvaMed) Standards Section and Science & Technology Section. He recently retired as the convenor of the ISO/TC210, Working Group 1 on quality systems, the administrator of ISO 13485, medical devices – quality management systems – requirements for regulatory purposes. He has coauthored a reference book, The FDA and Worldwide Quality System Requirements Guidebook for Medical Devices, 2nd edition, ASQ – Quality Press, 2008.

He received a B.S. degree in mechanical engineering from Cornell University and a J.D. degree from the Seton Hall University School of Law.

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Refund Policy

Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.

If you have any concern about the content of the webinar and not satisfied please contact us at below email or by call mentioning your feedback for resolution of the matter.

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