Actually I am a Principle Design Assurance Engineer and I would like to correct something about Risk Management. Actually the purpose of ISO 14971 is to eliminate unnecessary risk.
I'm not sure we can say that an internal standard has only one purpose. I'm sure Edwin Bills (one of the authors) could list of multiple reasons why we need ISO 14971 (e.g., it is a foundational tool for documenting how electrical safety is ensured for electromedical devices in IEC 60601-1).
In general, I try to use risk controls to develop products that are better and safer than competitor products as a way to differentiate the product. If I can't do that, the project is not very interesting to me. That's why I love working on breakthrough designation products and STeP projects. The complete phrase in the EU regulations is "As far as possible when considering the state of the art." Therefore, you have to perform PMS surveys to determine what is state of the art. Then you know what "AFAP" is. I also focus a lot more on elimination of risks by design, while most people (including the FDA) rely too heavily on warnings.
Actually I am a Principle Design Assurance Engineer and I would like to correct something about Risk Management. Actually the purpose of ISO 14971 is to eliminate unnecessary risk.
I'm not sure we can say that an internal standard has only one purpose. I'm sure Edwin Bills (one of the authors) could list of multiple reasons why we need ISO 14971 (e.g., it is a foundational tool for documenting how electrical safety is ensured for electromedical devices in IEC 60601-1).
Are you an ALARA or ALARP guy? 😅 In all seriousness, how do you know when risk has been mitigated as much as possible?
In general, I try to use risk controls to develop products that are better and safer than competitor products as a way to differentiate the product. If I can't do that, the project is not very interesting to me. That's why I love working on breakthrough designation products and STeP projects.
The complete phrase in the EU regulations is "As far as possible when considering the state of the art." Therefore, you have to perform PMS surveys to determine what is state of the art. Then you know what "AFAP" is. I also focus a lot more on elimination of risks by design, while most people (including the FDA) rely too heavily on warnings.
Thank you. Very informative.
You are welcome!