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      • And more…
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January 2025


EU Declaration of Conformity

By Florian KrafftJanuary 27, 2025Leave a comment

In this article you will learn,

DAkkS: The German Accreditation Body

By Prof. Dr. Christian JohnerJanuary 27, 2025Leave a comment

The DAkkS, the German Accreditation Body, is Germany’s national accreditation authority.

Declaration of Interest

By Dr. Anja KuhnertJanuary 24, 2025Leave a comment

A declaration of interest is a formal document designed to make potential conflicts of interest transparent. Individuals submit a declaration of interest to demonstrate their objectivity and independence. This article is about declarations of interest in a clinical context.

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Artificial intelligence in medicine

By Dr. Tina PriewasserJanuary 15, 20251 Comment

More and more medical devices are using artificial intelligence e.g., to diagnose patients more precisely and to treat them more effectively.

Closed-loop systems in medical devices

By Mario KlessascheckJanuary 14, 2025Leave a comment

Medical devices are increasingly based on closed-loop systems. These “closed-loop systems” are already mentioned in the Medical Device Regulation (MDR). One example is a system consisting of an insulin pump controlled by a device with a glucose sensor. In this article, you will learn what closed-loop systems are, where they are used in medicine, and what…

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Supplier evaluation – supplier selection – supplier audits

By Ulrich HafenJanuary 8, 2025Leave a comment

The MDR and IVDR, as well as ISO 13485:2016, just like the FDA, set out clear requirements regarding supplier evaluation, supplier selection, and supplier monitoring. This article not only gives you an overview of the regulatory requirements. It also gives you tips on how to implement them and tells you when a supplier audit is necessary.

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Medicinal product or (substance-based) medical device?

By Dr. Manuela ReinholdJanuary 1, 2025Leave a comment

The classification of whether a device is a medicinal product or a substance-based medical device has far-reaching regulatory consequences. This classification is so demanding that there are regular disputes with authorities and notified bodies, and in 2023, even the European Court of Justice had to rule on the matter. This article helps manufacturers, authorities, and…

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