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).
Thank you. Very informative.
You are welcome!
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).