Health Canada Medical Device Regulations 
&
 CMDCAS Requirements

 

cmdcas Health Canada Medical Device Regulations 
&
 CMDCAS Requirements

This webinar provides an overview of critical regulatory and licensing requirements of the Health Canada Medical Device Regulations and CMDCAS. Examples include Mandatory Problem Reporting and the 7 Steps to Canadian Distribution.

You will learn about the differences between ISO 13485 and the CMDR, as well as how to identify changes to the CMDR. 

Also included are information resources links for Health Canada recalls, Canadian Guidance Documents, GD210 and more.  

Excerpt below from Robert Packard, Medical Device Academy

“Identifying New and Revised Canadian Medical Device Regulations-Step 1 – You need to look up the most recent version of the CMDR (http://bit.ly/FindCMDR). This link tells you how to search for the Medical Device Regulations on the Justice Canada website (http://bit.ly/Justice-Canada). When you type in “Medical Device Regulations” in the proper search field, it will take you to a page with a link for Canadian Medical Device Regulations (i.e., CMDR or SOR/98-282; http://bit.ly/CanadianMDR). Then you can decide if you want to download the CMDR in HTML, XML or PDF format. Why not click directly on the last link I provided? Because the location on the Justice Canada website may change, and Health Canada does not control the Justice Canada website.” – How to Identify New and Revised Canadian Medical Device Regulations

 This recording is only $129.00

cmdcas2 Health Canada Medical Device Regulations 
&
 CMDCAS Requirements
Health Canada Medical Device Regulations 
&
 CMDCAS Requirements

This webinar provides an overview of critical regulatory and licensing requirements of the Health Canada Medical Device Regulations and CMDCAS. Examples include Mandatory Problem Reporting and the 7 Steps to Canadian Distribution.

Price: $129.00

exam2 150x150 Health Canada Medical Device Regulations 
&
 CMDCAS Requirements
EXAM – Health Canada Medical Device Regulations 
and CMDCAS Requirements

This is a 10 question quiz with multiple choice and fill in the blank questions. The completed quiz is to be submitted by email to Rob Packard as an MS Word document. Rob will provide a corrected exam with explanations for incorrect answers and a training effectiveness certificate for grades of 70% or higher.

Price: $49.00

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SOPS Health Canada Medical Device Regulations 
&
 CMDCAS Requirements

About Your Instructor

Medical Device Academy Robert Packard Health Canada Medical Device Regulations 
&
 CMDCAS Requirements Robert Packard is a regulatory consultant with 20 years experience in the medical device, pharmaceutical and biotechnology industries. He is a graduate of UConn in Chemical Engineering. Robert was a senior manager at several medical device companies—including President/CEO of a laparoscopic imaging company. His Quality Management System expertise covers all aspects of developing, training, implementing, and maintaining ISO 13485 and ISO 14971 certification. From 2009-2012, he was a lead auditor and instructor for one of the largest Notified Bodies. Robert’s specialty is regulatory submissions for high-risk medical devices, such as implants and drug/device combination products for CE marking applications, Canadian medical device applications and 510(k) submissions. The most favorite part of his job is training others. Specialties: CE Marking, Canadian Medical Device Applications, Post-Marketing Activities, Supplier Quality, CAPA, Risk Management, Auditing, Sterilization Validation, Lean Manufacturing, Silicone Chemistry, Extrusion, Bioprocess Engineering, and Strategy. He can be reached via phone 802.258.1881 or email. You can also follow him on Google+, LinkedIn or Twitter.

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