Medical Device Stand-Alone Software Under the UK MHRA
Following a trend…
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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…
Leveraging Device Clinical Data in Great Britain for IVDR Performance Evaluations
One of the challenges being experienced by IVD manufacturers, in meeting the requirements of the IVDR, is ensuring (and…
IVDD vs IVDR: Greatest Impacts on IVD Manufacturers
The IVDR has brought about a paradigm shift in the regulatory framework for IVDs placed on the…
EU Importation and Taxation Considerations: DDP vs DAP
Asides from the regulatory hurdles necessary to navigate when marketing your devices in the EU, taxation requirements are also…
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