This AI guideline / checklist is supposed to serve medical device manufacturers, notified bodies and authorities to
- gain a common understanding of AI related requirements and best practices
- guide the development, verification and validation as well as the post-market surveillance of medical devices that incorporate machine learning algorithms
- guide the compilation and the review of the respective technical documentation
- guide the adaptation of SOPs, process descriptions and work instructions as well as compliance checks e.g. as part of audits
The authors appreciate any feedback and active contributors.
- German version of the AI Guideline
- English version of the AI Guideline
- English and German version as Excel Files for convenient filtering and printing: Available on Johner Institute's website
- Templates for documenting the AI relevant aspects e.g. for submission files: Available as part of the Auditgarant (e-learning library with 200+ training videos and 100+ templates)
Unfortunatelly Github is unable to display the footnotes properly. This is why they are shown in a format like [^B2-01]:.