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The three Cs in risk management

The three Cs in risk managementImplementing risk management into the medical device development process has become a regulatory necessity. As a result, more and more translation service providers are implementing risk management systems. Unfortunately, many companies struggle to not only fulfill the requirements of ISO 14971, but also to find ways to implement risk management into the overall operating framework in a meaningful way.

One area that causes particular challenges is the validation stage. A good way to overcome some of the problems is to keep in mind the "three Cs": Completeness, Correctness and Coverage.

Make sure that you are complete – did you really test everything that you needed to test?

Make sure you are correct – did you test what you’re supposed to test? There are many cases where people thought they were testing something and in reality they did something completely different.

Coverage means you cannot test 100%. Specifically in software that is very difficult. So you have to be able to test as well as possible by using certain testing strategy. (It is a good practice to at least estimate your test coverage for your test cases.)

One final tip: If you want to implement a risk management system, use ISO 14971 as a template. The ISO standard is basically a Standard Operating Procedure (SOP). If you use it as a template for your risk management system, you will just have to adapt it to other procedures within your company.


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