adminMTE_04792023-04-21T14:02:41+00:00October 21st, 2020|Categories: Clinical Trial, Europe, USA|Tags: Clinical Trial, Europe, IMDRF, Regulatory, USA|
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 [...]
adminMTE_04792020-04-24T11:04:01+00:00April 24th, 2020|Categories: Compliance, Europe, Innovation, Regulatory, Software, USA|Tags: Clinical Trial, Europe, IMDRF, Regulatory, USA|
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: Principles [...]
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