EU MDR Software as a Medical Device (SaMD)

Free Guidance Document + Gap Assessment Tool



What is included?
  • Guidance Document for EU MDR: Software as a Medical Device (SaMD)
    • Overview of SaMD under 1993 Medical Device Directive (MDD) & 2017 Medical Device Regulation (MDR)
    • Classification changes from MDD to MDR and guidelines on how to classify your SaMD
    • Regulatory pathway routes and how to choose the best one for compliance with MDR
  • SaMD Audit Gap Assessment Tool
    • Access 3 separate templates to assess your SaMD compliance with requirements from:
      • EU MDR
      • BS EN 62304
      • IMDRF
SaMD-MDR-content-pkg-CTA_pharmi med


Free Guidance Document + Gap Assessment Tool

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ABOUT Pharmi Med Ltd

Pharmi Med Ltd. is a rapidly growing regulatory and compliance consultancy which has served the Medical Device and Pharmaceutical manufacturing industries since 1999. Pharmi Med Ltd has a strong reputation of delivering on projects, ensuring satisfactory audits and patient safe products.

We offer solutions to manufacturers where budgets are restrained and permanent headcount is not the answer. With ever changing regulations, we take on the responsibility to stay informed and implement the requirements so that manufacturers can focus on production. We aim to ensure you have a competitive advantage by ensuring your products are meeting US FDA and EU requirements, as well as any other global market.

Pharmi Med Ltd is a member of Medilink and Bionow. We are also IRCA certified so that you can be rest assured your audits will be performed at a global standard.. Visit our website to learn more by clicking here.