When the Medical Device Single Audit Program (MDSAP) pilot started on 1 January 2014, the idea was simple: one regulatory
Manufacturers have been able to register in EUDAMED, the European database on medical devices, since December 2020 for the Actor
Using the EUDAMED UDI/Devices module became mandatory on 28 May 2026. This follows the Commission Decision (EU) 2025/2371, which formally
FDA 21 CFR Part 820 is now the Quality Management System Regulation (QMSR). The final rule was published in the
The Medical Device Regulation (EU) 2017/745 (MDR) has applied since 26 May 2021, yet software manufacturers are still working through
We are pleased to welcome Eva Kurilova-Sahin to the MedQAIR team. Eva brings a background in medicine, clinical science, radiology,
Post market surveillance (PMS) for medical devices is the system a manufacturer uses to collect and analyse data on its
The EU declaration of conformity is usually the shortest document in a medical device file, and it is often the
When Regulation (EU) 2017/745 (MDR) started to apply on 26 May 2021, it brought in Rule 11, a classification rule
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