Medical devices consulting
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Train your team

With developing regulations and differing requirements for devices, it is important to ensure that your team are fully trained and have the know-how to comply with the required standards.

The strategic partnership between Pharmaceutical Development Services Limited and High Edge Consulting Limited provides clients with the ability to train your teams in medical devices regulatory frameworks and quality systems.

Training Courses

  • CE Marking - An introduction to the Medical Devices Directive

  • Compilation of a Technical File /Design Dossier

  • Biological Evaluation of medical devices ISO 10993-1

  • ISO 13485 Internal Auditor

  • Preparing for Regulatory Audit

  • Designing for Sterilization

  • Risk Management of Medical Devices

  • Sterilization - Ethylene Oxide (advanced)

  • Sterilization - Gamma 7 electron beam (advanced

For further information regarding any of the courses above, or if you would like to discuss your specific medical device training requirements, please contact PDS today.