FDA GFI, Procedures for Handling Post-Approval Studies Imposed by Premarket Approval Application Order, 10/22 Beatrice Burtsov2022-11-09T10:13:01+00:00November 9th, 2022|
MDCG 2022 7 Q&A on the Unique Device Identification system under MDR/IVDR, 05/22 Beatrice Burtsov2022-11-08T13:20:31+00:00November 8th, 2022|
IMDRF Medical Devices: Post Market Surveillance National Competent Authority Report Exchange Criteria and Report Form, 04/23 Beatrice Burtsov2023-07-24T13:21:44+00:00September 7th, 2022|
FDA GFI, Real World Data: Assessing Electronic Health Records and Medical Claims Data, DRAFT, 09/21 Beatrice Burtsov2022-01-28T08:45:13+00:00January 28th, 2022|
FDA GFI, Investigator Responsibilities – Safety Reporting for Investigational Drugs and Devices, DRAFT, 09/21 Anna Sandberg2021-10-28T12:22:04+00:00October 28th, 2021|
MDCG 2020 10/1 Safety reporting in clinical investigations of medical devices under the Regulation (EU) 2017/745, 05/20 Anna Sandberg2021-10-12T07:49:47+00:00October 12th, 2021|