Inhaber der Johner Institut GmbH
A ‘Request for Information’ can (partially) avoid expensive legal fees. Just ask the authorities directly! This way, you will get a qualified answer, even if it is not free of charge. Read here to find out
DetailsSome Medical Device Regulation (MDR) changes affect all medical device manufacturers. Some of these changes are particularly aimed at manufacturers whose products contain software or are standalone software. Read on to find out what these manufacturers should be aware of.
Laws and standards (e.g., FDA, ISO 13485) require “objective evidence.”
Most medical device manufacturers associate the term “design validation” with the FDA. However, not only the FDA but also European regulations, particularly ISO 13485, require design and development validation. Nevertheless, design validation and validation of the design should not be confused. This article shows how the two differ and which regulatory requirements must be observed.
DetailsWhen selecting an operating system, do medical device manufacturers have to ensure that the operating system is IEC 62304-compliant? What does the FDA say? This article…
Configuration management is much more than using version management tools like git or svn. This becomes clear when you look at IEC 62304 and the FDA guidance documents. In this article, you will read about
DetailsAccessibility refers to the design of products and services that can also be used by people with physical limitations. The term “products and services” encompasses both physical and digital products and services. This also includes medical devices (physical devices, apps, other standalone software). This article explains which accessibility requirements manufacturers of medical devices should be…
DetailsOn September 14, 2024, the new version of the German Health Interoperability Governance Regulation (or IOP Governance Regulation, or GIGV for short) came into force. The German Ministry of Health published a draft bill (only available in German) containing the recitals on April 24 of that year. This version of the GIGV will replace the…
DetailsCyclomatic complexity is a metric in software engineering that helps determine the complexity and, thus, the likelyhood of errors and the maintainability of code. Cyclomatic complexity is also referred to as the McCabe metric.
Companies need to master the digital transformation quickly and successfully. This also applies to medical device manufacturers because, after all, their future depends on it. Many companies make severe mistakes during this transformation (see section 4). This article provides managers with a quick overview of the possibilities of digital transformation and gives seven tips to make it…
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