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Angola Global Hub

Medical Devices and EU MDR Training

For those who manufacture, distribute or want to place medical devices on the European market, the EU MDR is the frontier to master. These programmes prepare teams for the regulatory requirements that open access to the market.

Available programmes

  • ISO 13485:2016, internal auditor for medical devices.
  • Clinical Evaluation under the EU MDR.
  • CE Marking for Medical Devices (EU MDR 2017/745).
  • Post-Market Surveillance.
  • Technical Documentation (annexes II and III).
  • Sterilisation of Medical Devices.
  • Process Validation, from concept to monitoring.
  • Cleanroom Compliance.
  • MDSAP, fundamentals for market access.
  • eIFU Compliance.
  • Person Responsible for Regulatory Compliance (PRRC).
  • EUDAMED in practice.
  • PMCF.
  • Biocompatibility.
  • Navigating AI in medical devices.

Model

In person or in-company, materials in English, DQS Academy certificate.

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Frequently asked questions

Yes, the EU MDR governs the access of medical devices to the European Union market.

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