EUDAMED User Guide: SSCPs and Certificates
The European Commission published the updated EUDAMED User Guide – Notified Bodies & Certificates…
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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…
The Role of Regulatory Affairs in Product Development
In the complex and highly regulated world of medical…
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…
Medical Device Software in the EU: A Guide to Compliance and Market Entry
Medical Device Software (MDSW) including Software as a Medical Device (SaMD) is rapidly transforming healthcare delivery. The regulatory framework for SaMD in…
IVD Risk Management: Known and Foreseeable Hazards in Normal and Fault Conditions
It has long been a requirement under the ISO 14971 standard…
MDR EU Regulation Requirements: Systems and Procedure Packs
Under Article 2 of the MDR, a “system” is a combination of products, either packaged together or not, which are…
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