MHRA Update Regarding Adverse Incidents Reporting
As of August 31, 2023, there are changes to how adverse incidents involving medical devices should be reported to…
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New Swissmedic Swissdamed Medical Device Registration
Due to the status of the agreement on mutual recognition of conformity assessments (MRA) between Switzerland and the…
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 Incident Reporting: Why Manufacturers Need to Be more Aware
The Dutch Health and Youth Care Inspectorate (the Inspectorate) suggests manufacturers be more aware of medical device incident reporting. In…
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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