I came across an article online that highlights 4 reasons why a company’s risk management approach may be wrong. It was an interesting read and indicates the following as major errors:

1. Risk management and design controls are separate processes – Risk management and design controls both aim to ensure that medical devices are safe and effective. Companies should be able to demonstrate how risk controls lead to an improvement in product design, which results in design verification and validation.

2. Risk management is a “checkbox” activity – Instead of looking as risk management as an errand that can be done later, it should be looked at as an opportunity to improve product design. The ISO 14971 can be used as a guideline to figure out the steps of risk management and what should be documented.

3. FMEA is being used as risk management – Companies are trying to use FMEA to satisfy ISO 14971 Risk Management. While FMEA is about device failures, risk management is a holistic approach that analyzes risks involved with device usage and failures.

4. Risk management is not a lifecycle process – Many companies only perform risk management during product development but do not continue once production begins. Instead, the risk management file should be treated as a living document. Processes should be able to be updated according to complaints, feedback, CAPAs, and other events that occur after the product is out on the market.

What are your thoughts on these major mistakes that medical device companies make and are there others that you would like to add on?

http://blog.greenlight.guru/why-your-risk-management-approach-is-wrong