Device listing is the part of FDA registration that most teams touch once a year and otherwise forget. That is
ISO 27001 Requirements: A Clause-by-Clause Reference ISO/IEC 27001 has been the reference standard for information security management systems since 2005,
21 CFR Part 11 began as a permission, not a mandate. The FDA published it in March 1997, in 62
The shift from Directive 98/79/EC to Regulation (EU) 2017/746, the In Vitro Diagnostic Regulation, changed the route to IVD CE
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
We are pleased to welcome Eva Kurilova-Sahin to the MedQAIR team. Eva brings a background in medicine, clinical science, radiology,
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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