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Clinical Evaluation of Medical Devices

This course covers the requirements for Clinical Evaluation of Medical Devices. On completion of this course, participants will have a strong foundational knowledge of Clinical Evaluation.

Course Details

The aims and learning outcomes of this course are:

  • To understand the regulations regarding the Clinical Evaluation of Medical Devices in their organisation.
  • To appreciate the EU and global requirements of the Clinical Evaluation of Medical Devices.

This course is suitable for those who are:

  • Implementing a Clinical Evaluation in their organisation.
  • Checking a Clinical Evaluation meets requirements of CE and SFDA.
  • Quality Engineers and/or Regulatory Affairs professionals.

Following completion of this course, participants should:

  • Have an appreciation of the requirements for Clinical Evaluation, Post-Market Clinical Follow-up, Post-Market Surveillance and vigilance.
  • Recognise where Clinical Evaluation fits in the legal framework.
  • Be able to continuously update the Clinical Evaluation Report practically.
  • Conduct Post-Market Clinical Follow-up and Post-Market Surveillance.
  • Write an SSCP, a PSUR and a PMS plan and report.
  • Conduct vigilance and setting limits and recognise trigger points.
  • Understand QMS considerations, additional procedures and what they should cover.

This is a two day course in which participants will fully engage with the lecturer through group and individual exercises.  There are plenty of opportunities to ask questions and the course can be fully tailored to the company’s products and internal structure. 

This course works through the Clinical Evaluation requirements and is broken down into 5 modules.

  1. Introduction.
  2. Plan.
  3. Data.
  4. Investigation and PMS.
  5. Vigilance.