How to Achieve CMDCAS Certification (For Medical Device Companies That Want to Sell in Canada)

This webinar on CMDCAS certification will help you understand the process for upgrading an existing Quality Management System from an ISO 13485:2003 certificate to ISO 13485:2003 with CMDCAS.

Why Should You Attend:

This webinar will provide valuable assistance to all medical device companies in preparing for a CMDCAS upgrade. The focus will be upon creating an outline of the tasks that need to be completed—without confusing everyone with regulatory jargon.

This 60-minute session will will help you understand the process for upgrading an existing Quality Management System from an ISO 13485:2003 certificate to ISO 13485:2003 with CMDCAS. This is a prerequisite for obtaining a Canadian Medical Device License. You will learn how to budget resources (time & money), which guidance documents you will need, best practices for scheduling your upgrade audit, which procedural changes your company needs to make, what additional internal auditing is expected, and how to make sure that your registrar is recognized by Health Canada.

Areas Covered in the Webinar:

The webinar will include the following critical information you will need:

1. Which registrar is no longer able to issue CMDCAS certificates.
2. Where to find the list of 16 registrars that are recognized by Health Canada.
3. How to download your own audit checklist for Canadian Medical Device Regulations (CMDR)
4. Weaknesses with the audit checklist and how to fix it.
5. The easiest way to determine what is new in the latest update to the CMDR (September 19, 2012)
6. Best practices and common mistakes in writing procedures specific to the CMDR.
7. The most common nonconformities issued by registrars.
8. How long it will take you to achieve CMDCAS certification.
9. When you should not bother seeking CMDCAS certification.

Who will benefit:

This topic applies to personnel/ companies in the medical device industry. The employees who will benefit most include:

• Senior management,
• Regulatory affairs,
• Quality Assurance,
• Documentation,
• Product Management,
• IT/IS,
• Contract manufacturers.