Medical software includes all software used for healthcare, particularly for medical devices or medical devices (embedded software), and software that is itself a medical device (standalone software).
IEC/CD1 82304-1 (Health Software – Part 1: General requirements for product safety) distinguishes between the following terms:
This clarifies that medical software can be a medical device but does not have to be.
Fig. 1: Medical software includes medical device software and software as a medical device (click to enlarge).
The question often arises as to when medical software meets the definition of a medical device. You can find a further discussion on this topic in the article on the classification of software as a medical device and in the article on the qualification and classification of IVD medical device software.
Software that is a medical device or part of a medical device must meet the regulatory requirements:
Read more about legally compliant software development and IEC 62304 here.
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Laws require risk management in hospitals, especially in order to improve patient safety. Nevertheless, many hospitals find this difficult. This article presents the most important regulatory requirements and provides tips for implementation.
DetailsThe qualification and classification of IVD software determine how and how quickly IVD manufacturers can bring their software to market and what costs arise for “approval.” This article will help you correctly qualify and classify IVD software, thereby avoiding regulatory problems and the resulting costs and delays.
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DetailsThe Medical Device Regulation (MDR) (like the Medical Device Directive (MDD) and thus the Medical Device Act before it) requires manufacturers to comply with life cycle processes for their software. IEC 62304 and IEC 82304 also refer to software life cycle processes. But what is a software life cycle?
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Both the FDA and IEC 62304 recognize software developed by third parties. They refer to Off-the-Shelf Software (OTS) and Software Of Unknown Provenance (SOUP). What is the difference between OTS and SOUP? What do they have in common? What legal requirements do they have to meet? This article provides answers.
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DetailsThe term “medical device PC” is not clearly defined. However, most people understand a medical device PC to be Depending on the constellation, manufacturers must fulfill different regulatory requirements. These are presented in this article.
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