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MEDICAL DEVICE ESTABLISHMENT LICENCE (MDEL) SERVICES

Since 1999, we have helped various companies to obtain Medical Device Establishment Licences (MDELs). Therefore, based on our experience, and on our thorough knowledge of the Canadian medical device regulations and ISO 13485 / 13488, we are pleased to offer the following establishment licencing services:

We can:

  1. Determine if ISO 13485 or 13488 are required, or if your company can be exempted.

  2. Determine if Health Canada’s Quality Management System (QMS) can be implemented instead.

  3. Assist with the training, implementation & auditing of your Quality Assurance programme.

  4. Obtain and help complete all Establishment Licence applications.

  5. Identify and obtain price quotes from accredited ISO 13485 / 13488 registration auditors.

  6. Be the technical liaison between the registration auditor and the company, during the official audit.

  7. Perform annual internal audits thereafter, on behalf of the company.

ISO 13485 / 13488 SERVICES

Please click here to see our list of services related to:

  1. Training;

  2. Implementation; and

  3. Auditing.

OTHER ESTABLISHMENT APPLICATION SERVICES

We can:

  1. Determine Health Canada’s timeline goals for screening and reviewing the application.

  2. Determine the fees charged by Health Canada to screen and review the application.

  3. Determine if your company is eligible for applying for a fee reduction. If so, obtain and forward the fee reduction request to you.

  4. Identify the amount of time Health Canada expects responses to any requests for clarification.