EU Declaration of Conformity
In this article you will learn,
DAkkS: The German Accreditation Body
The DAkkS, the German Accreditation Body, is Germany’s national accreditation authority.
Declaration of Interest
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.
DetailsArtificial intelligence in medicine
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
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…
DetailsSupplier evaluation – supplier selection – supplier audits
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.
DetailsMedicinal product or (substance-based) medical device?
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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