The clinical evaluation literature search: 6 tips to save you time and stress

The literature search is a key part of the clinical evaluation. It usually involves numerous hours of work. This article will give you six tips to help you efficiently carry out and fully document the literature search. In the literature search, manufacturers gather together scientific articles, among other reasons, to document the state of the…

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Device category, generic device group, medical device family: Do not confuse them!

The MDR and IVDR use the terms device category and generic device group without fully defining them. ISO 13485:2016 introduces the medical device family. Finally, the MDCG uses the term device range. The definitions of these terms determine the allocation of UDIs and the sampling of product files during certification. Therefore, it is important for…

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Regulatory update: How to stay up to date with regulatory requirements

Medical device manufacturers are required to carry out a regular “regulatory update.” Because as strange as it sounds, regulatory requirements oblige manufacturers to continuously monitor and evaluate changes to regulatory requirements and take any necessary measures. Keeping track of thousands of regulatory requirements is a challenge. Manufacturers should have a clear understanding of the typical…

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Validation of machine learning libraries

More and more manufacturers are using machine learning libraries, such as scikit-learn, Tensorflow, and Keras, in their devices as a way to accelerate their research and development projects. However, not all manufacturers are fully aware of the regulatory requirements that they have to demonstrate compliance with when using machine learning libraries or how best to…

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