Device listing is the part of FDA registration that most teams touch once a year and otherwise forget. That is
Section 513 of the FD&C Act, added by the Medical Device Amendments of 28 May 1976, sets up FDA's three
FDA has classified more than 1,700 distinct types of devices and organised them into 16 medical specialty panels in 21
The MDR, Regulation (EU) 2017/745, was adopted on 5 April 2017 and has applied since 26 May 2021, replacing Directives
ISO 27001 Requirements: A Clause-by-Clause Reference ISO/IEC 27001 has been the reference standard for information security management systems since 2005,
FDA's Medical Device Recalls database lets you filter recalls by root cause. Six of the categories are about software: software
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
The EU made cybersecurity an explicit requirement for medical devices when the MDR started to apply on 26 May 2021,
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