Updated EUDAMED Timeline for Modules
The European Commission (EC) has published an updated EUDAMED timeline in relation to the roll out of…
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Ensuring ISO 13485 QMS Compliance
Organizations claiming compliance with ISO 13485 or possessing…
MDCG 2020-16 Guidance: Classification Rules for IVDs
The Medical Device Coordination Group (MDCG) has published an update to guidance document MDCG 2020-16 Rev.3 –…
WHO and GMDN Medical Device Collaboration for Communication
The GMDN Agency was established to provide a system that allows an exchange of medical device information for Health Authorities…
MHRA Clinical Investigations Guidance for Medical Devices
The UK has updated its guidance on notifying the Medicines and Healthcare products Regulatory Agency (MHRA) about…
Swissdamed Database Launch: August 2024 Update
Swissmedic has recently announced the first module of the Swissdamed Medical Devices Database will go live on…
MDCG 2021-5 Guidance: Standardization for Medical Devices
As of July 2nd, 2024, MDCG 2021-5 Rev.1 – Guidance on Standardization for Medical Devices, has been…
TGA Software Guidance: Regulations and Exclusions
There was a new guidance released by The Australian Therapeutic Goods Administration (TGA) which aims to…
TGA Classification Tool for Medical Devices and IVDs
The Australian Therapeutic Goods Administration (TGA) has released an online classification tool to help medical…
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