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Risk Analysis of Medical Devices

This course covers the requirements for Risk Management of Medical Devices and IVDs. By the end of this course, participants will have a strong foundational knowledge of how to conduct an effective Risk Analysis.

Course Details

The aims and learning outcomes of this course are:

  • To understand the requirements for risk analysis of Medical Devices and IVDs.
  • To be able to actively participate in the Risk Analysis of Medical Devices and IVDs.

This course is suitable for those who are:

  • Implementing the Risk Analysis requirements of ISO 14971:2019.
  • Checking a Risk Analysis meets the requirements of CE and SFDA.
  • Quality Engineers and/or Regulatory Professionals.

Following completion of this course, participants should:

  • Be in a position to write a risk procedure and a risk policy.
  • Understand the value of a risk plan and be able to develop a basic plan for a medical device.
  • Be able to actively participate in risk management of a medical device.
  • Be in a position to create an FMEA and risk report.
  • Be able to develop a Post-Market Surveillance plan and associated reports.

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 explores the requirements of Risk Analysis and is broken down into 5 modules.

  1. Introduction.
  2. Plan.
  3. Analysis.
  4. PMS.
  5. Vigilance.