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.
DetailsInternal audits: Avoid the 7 most common mistakes
Internal audits are inspections of the quality management system (QM system) and its processes by the organization itself. This is why they are also called 1st party audits. ISO 13485 requires internal audits like its “sister standard,” ISO 9001, and other standards and regulations. Therefore, internal audits are also a subject of external audits and…
DetailsRegulatory requirements for medical devices with machine learning
The incorporation of AI in medical devices has made great strides, for example, in the diagnosis of disease. Manufacturers of devices with machine learning face the challenge of having to demonstrate compliance of their devices with the regulations. Even if you know the law – what are the standards and best practices to consider in…
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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