FDA GFI, Clinical Decision Support Software, 09/22 Beatrice Burtsov2022-10-04T15:00:08+00:00October 4th, 2022|
IMDRF Machine Learning-enabled Medical Devices: Key Terms and Definitions, 05/22 Beatrice Burtsov2022-09-07T16:05:26+00:00September 7th, 2022|
FDA GFI, Policy for Device Software Functions and Mobile Medical Applications. 09/19 Beatrice Burtsov2022-04-05T14:07:04+00:00April 5th, 2022|
MDCG 2021 11 Guidance on Implant Card – ‘Device types’, 05/21 Beatrice Burtsov2022-03-03T12:42:27+00:00March 3rd, 2022|
FDA Health Canada and MHRA Guiding Principle, Good Machine Learning Practice for Medical Device Development, 10/21 Beatrice Burtsov2022-01-27T14:17:27+00:00January 27th, 2022|
FDA GFI, Content of Premarket Submissions for Device Software Functions, DRAFT, 11/21 Anna Sandberg2023-06-27T09:28:31+00:00November 10th, 2021|