Operating system compliant with IEC 62304 and FDA?
When 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…
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Configuration management for medical devices
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
Accessibility 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…
DetailsIOP Governance Regulation (GIGV) – What manufacturers can expect
On 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
Cyclomatic 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.
7 tips for the successful digital transformation of medical device manufacturers
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…
DetailsVerification and validation: Differences and definitions
What is the difference between verification and validation, and how are these terms defined? Even standards and regulations use the terms incorrectly or misleadingly. This article
DetailsThe most frequently asked questions about the quality management system
This FAQ provides answers to the most common questions that companies such as medical device manufacturers have about quality management systems (QM systems) and ISO 13485.
Phantoms in medical technology
Phantoms in medical technology help to develop, validate, “approve” and monitor medical devices in the markets faster and more effectively. This article describes which organizations particularly benefit from the use of these phantoms and what requirements they must meet.
DetailsWhat manufacturers need to know about legacy devices
Legislators are continually changing the regulatory framework for medical devices, as we have seen in Europe with EU Regulation 2017/745 (MDR) and EU Regulation 2017/746 (IVDR). This then raises the question of how to deal with legacy devices. These are the medical devices that manufacturers have legally placed on the market under the old directives…
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