With you we ensure compliance all national regulations including  MDR EU regulation (EU) 2017/745 and IVDR regulation (EU) 2017/746 to enable your device(s) placement in your chosen market.

  • Standard Operating Procedures
  • Standards and Regulations
  • Distributor Agreements
  • Launch Planning
  • Distributor Training
  • Traceability
  • PMS Planning
  • Regulatory Clearance
  • Fulfilment Agreements
  • Distribution Controls
  • Distributor Registration
  • Audit and Monitoring

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