The International Medical Device Regulators Forum (IMDRF) issued an update on PMCF studies

2023-04-21T14:02:41+00:00October 21st, 2020|Categories: Clinical Trial, Europe, USA|Tags: , , , , |

The International Medical Device Regulators Forum (IMDRF) has issued an update proposal to its guidance on postmarket clinical follow-up (PMCF) studies for medical devices. The proposal will be open for consultation untill 11 December 2020. The update includes advice on [...]

IMDRF issues guidances on cybersecurity, personalized devices, conformity assessment bodies and terminologies for categorized Adverse Event Reporting (AER)

2024-02-26T11:42:11+00:00April 24th, 2020|Categories: Compliance, Europe, Innovation, Regulatory, Software, USA|Tags: , , , , |

The International Medical Device Regulators Forum (IMDRF) issued on April 20th four technical documents covering cybersecurity, personalized devices, conformity assessment bodies and terminologies for categorized Adverse Event Reporting (AER). Following, a short overview on the content of the guidelines: [...]

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