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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IVD Risk Management: Known and Foreseeable Hazards in Normal and Fault Conditions
It has long been a requirement under the ISO 14971 standard…
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 Device Regulatory Compliance: A Comprehensive Guide
While the focus of EU regulatory compliance for medical devices and…
PMPF Under the IVDR: Methods, Justifications, and Triggers
As we have mentioned in…
What is the Difference Between PMS and PMPF Under the IVDR?
While post-market clinical follow-up (PMCF) studies were a concept…
Linking IVDR Performance Evaluations and Risk Management
Similar to…
Performance Evaluation Reports Under the IVDR
The performance evaluation report (PER) is the culmination of the application of the performance evaluation process to a specific IVD…
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