Quality Management System

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Dedicated experts, a customized solution

The market requires medical device manufacturers to set up and maintain a quality management system (QMS) that complies with the numerous quality and regulatory requirements.

MD101 can help you to comply with the various quality assurance and regulatory standards applicable in the territories in which you wish to market your medical devices:

  • ISO 13485
  • 21 CFR part 820 (FDA)
  • Regulation EU 2017/745 (or EU 2017/746)
  • Other regulations in MDSAP countries (Medical Device Single Audit Programme) including Australia, Brazil, Canada, Japan and USA.

Whether you are a new player, in transition to MDR or targeting new standards, MD101 can help you set up and/or improve your QMS, to ensure compliance with regulatory and standards requirements.

MD101 is registered as an expert with BPI (French Public Investment Bank). Our support in setting up a quality management system may be covered by the BPI’s “Diagnostic Dispositif Médical” aid scheme.

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