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ISO 13485:2003 CMDCAS

CMDCAS ISO 13485 CanadaUnder Canada’s Medical Devices Regulations (MDR), medical device manufacturers must prove that the devices they market or sell are safe, effective and meet quality standards. Other than the lowest risk (Class I) items, all Medical Devices and In Vitro Diagnostic Devices (IVDDs) are required to meet specific quality criteria based on standards developed by the International Organization for Standardization (ISO).

To verify these requirements, manufacturers must contract with an independent registrar who is accredited by the Standards Council of Canada under the Canadian Medical Devices Conformity Assessment System (CMDCAS) and is recognized by Health Canada (the Canadian Ministry of Health).

A registrar confirms a manufacturer's quality management system operates in compliance with a Canadian version of ISO 13485 standards by assessing procedures and product management in the following main topic areas:

  • Document Control
  • Management Responsibility
  • Resource Management
  • Realization of the Product
  • Monitoring, Measurement and Improvement

Working with an experienced and recognized registrar, such as LNE/G-MED, can be one of your most important steps to ensure a smooth, efficient audit process, obtain valuable feedback on your quality processes and convey credibility to your customers, business partners and regulators.

MDSAP Prepare the transition, worldwide market access

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Due to our rapid growth in North America, we're seeking Lead Auditors, Certification Project Manager Active and Non-Active Medical Device responsible for medical device manufacturing clients.

Training - 2 Days Course

Training EU Medical Device Regulations

 

European Medical Device Regulation 2017/745

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Combo Training ISO13485 MDSAP

Transition to ISO 13485:2016

& The fundamentals of the Medical Device Single Audit Program (MDSAP) for Medical Device Manufacturers

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Our Clients Say

"We traveled from Massachusetts to attend the 2days LNE/G-Med ISO 13485:2016 and ISO 9001:2015 transition training and it was well worth the trip. The training was interesting, informative and interactive. The case studies were a great way to try and apply the new aspects of the standards and brainstorm with others. The chance to meet and discuss the new standards with actual LNE auditors was a huge plus."
Dan Massucco - Vice President of Quality Assurance and Regulatory Affairs

"I just thought you might like to know that we completed our transition audit with only three minor NCs. The auditor was very impressed that we did this on our own without the benefit of a consultant. I give much of the credit to your training class and want you to know that I really think you did an excellent job with the training."
Sue Powell - Quality Manager