Update to reflect current regulatory requirements

[ChristianRosenzweig]

Mandated to be harmonized under the EU-MDR: IEC 81001-5-1

Important for product related security considerations: IEC 60601-4-5

New FDA guidance: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cybersecurity-medical-devices-quality-system-considerations-and-content-premarket-submissions

[DanielMarcato]

The list has not been updated in quite a while. I am wondering if it is in fact even still usable at this point? @johner-institut

[ChristianRosenzweig]

Dear Daniel, you are absolutely right, the list needs a revision. We are currently working on it. You might have noticed that

• in Europe there is an upcoming harmonized standard IEC 81001-5-1 that has to be incorporated into our list contentwise
• in US there is a new Guidance for cybersecurity that needs to be included also Best regards Christian

[DanielMarcato]

Thank you @ChristianRosenzweig!

Do you guys have a timeline for when we can expect the update? I am currently in the process of incorporating your guideline into our processes after being trained with the @johner-institut 62304 material.

[ChristianRosenzweig]

@DanielMarcato: If you are working towards European medical device market I would focus on the IEC 81001-5-1 as it outlines the total product life cycle process regarding security. When you have implemented this into your quality management system (like the IEC 62304 process), the security guideline can have additional detail questions and can be used as a checklist in a final review.