EMA Questions and Answers: remote batch certification/confirmation by the qualified person (QP), 07/23 Anastasija Eschricht2023-08-17T08:35:45+00:00August 17th, 2023|
FDA GFI, Cybersecurity: Refuse to Accept Policy for Cyber Devices and Related Systems Under Sec 524B of FD&C Act, 03/23 Anastasija Eschricht2023-07-24T13:47:53+00:00July 24th, 2023|
IMDRF Principles and Practices for the Cybersecurity of Legacy Medical Devices, 04/23 Anastasija Eschricht2023-07-24T13:23:33+00:00July 24th, 2023|
IMDRF Principles and Practices for Software Bill of Materials for Medical Device Cybersecurity, 04/23 Anastasija Eschricht2023-07-24T13:16:48+00:00July 24th, 2023|
FDA GFI, Electronic Source Data in Clinical Investigations, 09/13 Anastasija Eschricht2023-07-24T13:15:09+00:00July 24th, 2023|
FDA GFI, Digital Health Technologies for Remote Data Acquisition in Clinical Investigations, DRAFT, 12/21 Anastasija Eschricht2023-06-27T11:50:00+00:00June 27th, 2023|
