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CMDCAS Certification and the Canadian MDR

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

Presenters:

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.

Ron. M Mathis

Mr. Mathis is SGS’s VP for Healthcare. In this role, he is responsible for the leadership of the Healthcare section, including Medical Device Certification and Training, as well as the delivery of auditing service within the Pharmaceutical 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.

Please see archived link below to view this webinar:

CMDCAS Certification and the Canadian MDR

Evaluating Critical Suppliers

Critical suppliers include subcontractors that perform high-risk processes, such as the manufacture of finished devices or major device components, special processes, calibration houses, test houses, contract sterilization, or contract packaging,. Both FDA QSR and EN ISO13485 and IMDRF guidance spell out some of the elements for control over critical suppliers, including the requirements for the manufacturer’s purchasing and production / service processes, best handshake practices with individual suppliers, and contractual agreements. This makes it necessary for a manufacturer to select suppliers wisely to ensure that the critical supplier can help meet regulatory requirements and remain a partner for an extended timeframe.
 
The webinar is aimed at providing quality management, procurement, financial and operations professionals with additional insights into a risk-based approach to identifying, evaluating, and controlling critical suppliers.

Topics include:  

  • Initial assessment, evaluation and selection of critical suppliers
  • Ongoing assessment of critical suppliers
  • Transition to new critical suppliers

Presenters:

Joyce Ludwig
M Squared Associates

The speaker has 30 years of experience in Quality Management Systems for both domestic and global implantable medical device organizations. Her unique perspective of partnering with suppliers has transformed the “low bid approach” into “quality initiatives” and creating stable, value-added, synergistic relationships with key critical suppliers. Joining with procurement, financial and operations departments to jointly review  initial assessments of critical suppliers provides consensus into decision making for selecting critical suppliers. 

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.  
 
Please see archived link below to view this webinar:

Evaluating Critical Suppliers