An Approach to PMS and PMCF for SaMD Startups
Medical Device Software (MDSW) (“Software”) developed by Medical Device (SaMD) startups, plays an important role…
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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…
Updated Guidance for UK Virtual Manufacturers of Medical Devices: Compliance Requirements
Virtual manufacturers of medical devices that do not need UK Approved Body/EU Notified Body approval are still required…
CE Marked Medical Devices in Great Britain: Timeline Extended
The UK Government has introduced the Medical Devices (Amendment) (Great Britain) Regulations 2023, allowing CE marked…
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…
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