EMA Guideline on computerised systems and electronic data in clinical trials, DRAFT, 03/21 Anastasija Eschricht2023-03-21T12:33:43+00:00March 21st, 2023|
EMA Notice to sponsors on validation and qualification of computerised systems used in clinical trials, 04/20 Anastasija Eschricht2023-03-16T14:29:27+00:00March 16th, 2023|
FDA GFI, Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions, DRAFT, 04/22 Anastasija Eschricht2022-12-07T10:21:35+00:00December 7th, 2022|
MDCG 2019 11 Guidance on Qualification and Classification of Software in 2017/745 MDR and IVDR, 10/19 Beatrice Burtsov2022-11-30T12:52:43+00:00November 30th, 2022|
FDA GFI, Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions, DRAFT, 04/22 Beatrice Burtsov2022-11-16T10:40:03+00:00November 16th, 2022|
OECD Number 17 Application of GLP Principles to Computerised systems, 04/16 Beatrice Burtsov2022-11-09T09:45:08+00:00November 9th, 2022|
