Risk Management in Medical Device Development

By 7 February 2019 News No Comments
Medical Device Risk Management

It is no secret that risk management isn’t the most exciting subject to speak about, but it is an essential part of all design and engineering, particularly for medical devices. Whether you’re new to the field of risk management, or are a seasoned pro, regularly reading and learning about the topic is essential to ensure you’re always using the best practices. One of our Associate Medical Device Consultants, Mike Heald from Commala, has put together a fantastic 8-part series on risk management covering everything from ‘what is an acceptable risk?’ to using FMEA or fault tree analysis. Links to each of the articles are below:

  1. Medical Device Safety Risk Management and Project Planning
  2. Safety Risk Management in Research
  3. What is Acceptable Risk?
  4. Multi-discipline Safety Risk Assessment
  5. Should I Use FMEA or Fault Tree Analysis?
  6. Safety Risk Management and Essential Design Outputs
  7. Risk Control Verification
  8. Not Doing Risk Management is Not an Option

Mike has eloquently explained each area in enough detail to give those with a good background a touch-up on their knowledge, and for those new to it a good understanding. Haughton Design take pride in our Associate Consultants, and knowledge like that from Mike is invaluable to both us and our clients. The articles can also be found on the Medilink website here.