EU MDR Risk Classification: Guide and Case Study
Manufacturers are responsible for determining…
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Annex II Under the MDR: What is a Technical File?
This article draws from our experience in conducting Tech-File reviews and outlines the key requirements for Technical Files based…
Clinical Investigation Under the MDR: When is it Not Mandatory?
Due to the resources necessary to perform a clinical investigation under the…
Performing Clinical Evaluations: Article 61(10) Under the MDR
Under Article 61(10) of the MDR,…
EUDAMED User Guide: SSCPs and Certificates
The European Commission published the updated EUDAMED User Guide – Notified Bodies & Certificates…
MHRA Guidance on SaMDs: Navigating the Regulatory Landscape
Software as a Medical Device (SaMD) is defined as software intended to be used for one or more medical purposes…
Medical Device Stand-Alone Software Under the UK MHRA
Following a trend…
An Approach to PMS and PMCF for SaMD Startups
Medical Device Software (MDSW) (“Software”) developed by Medical Device (SaMD) startups, plays an important role…
Medical Device Risk Assessment Under ISO 14971:2019
At the time of this article, it has been approximately four years since the publication of ISO 14971:2019. However, while…
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