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The European Union’s Medical Device Regulation commonly referred to as “MDR”, came into effect from May 26, 2021. It is intended to improve the quality of medical devices and promote a lifecycle approach for medical device regulation. Broadly, it is focused on enhanced quality and compliance with specific focus on the following:

  • The pre-approval stage of medical device manufacturing
  • Standardizing manufacturing practices
  • Ensuring compliance through data visibility, transparency and sustainability of quality metrics across the product lifecycle

This whitepaper kit is divided into the following broad topics:

  • MDR – a quick overview
  • Implications of MDR for device manufacturers
  • EUDAMED with its 6 interconnected modules
  • Role of QMS in ensuring compliance

This compliance kit also comes with directions to further checklists, whitepapers and webinars that will help you get a thorough perspective of what it takes to meet the EU MDR regulations.

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