Is your Quality Management System ready for the new MDR requirements?

 If you need to update your QMS because of the changes in the MDR, we have the perfect package deal that will keep you ahead of the game and compliant with the requirements.

This package contains training in MDR, an analysis of your QMS that will show what you need to update, and an internal audit of your entire QMS. 

Here is what you will get out of this tailor made QMS/MDR offer:

Three hour online training in ”MDR audit readiness”

  • The course will provide basic knowledge regarding the QMS requirements for MDR.
  • The training session includes up to 10 participants and you will all receive training certificates.

GAP analysis of your Quality Management System, regarding MDR

  • We will access your current QMS and perform a remote GAP analysis, regarding MDR.
  • The GAP analysis is then summarized in a report that will be sent to you, together with a Teams-presentation of the results.
  • You can now update your QMS according to the non-conformities that were found in the GAP analysis.
  • If needed, we can also help you with the updates.
    Not included in the package. We will provide a separate quote, tailored to your needs.

One day internal audit on your entire Quality Management System, regarding MDR

  • We plan the audit together with you. It will be performed for one day over Teams.
  • We can also add more criteria to the audit if needed. For example, ISO 13485:2015 and/or QSR.
  • The audit is summarized in an audit report. If you prefer, we can use your own template.

Package price

 SEK 69 000:-

Want to know more about this offer?

Get in touch with our specialists to see what your company can benefit from the package.

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