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.
Benefit from the support of the Johner Institute:
Contact us right away so that we can discuss the next steps. This will ensure that the “approval” is a success and that your software or devices are quickly launched on the market.
The 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?
1. Documentation Level: End of Level of Concern On June 14, 2023, the FDA released the guidance document Content of Premarket Submissions for Device Software Functions. This document replaces the guidance document introducing the Level of Concern and only distinguishes between two classes.
DetailsSoftware maintenance is the phase in which software is further developed, e.g., with the objective of According to the FDA, 79% of all bugs occur during software maintenance. Accordingly, some regulations address this topic.
DetailsMDCG published guideline MDCG 2023-4 in October 2023 entitled “Medical Device Software (MDSW) – Hardware combinations – Guidance on MDSW intended to work in combination with hardware or hardware components.”
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.
DetailsFor manufacturers, the answer to whether and when clinical studies are necessary when using artificial intelligence in medical devices is relevant. After all, the duration and cost of bringing these devices to market depend on this. The good news in advance: there are cases where manufacturers can avoid clinical studies for devices with AI. This…
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.
DetailsIEC 80001-1 has the long title “Application of risk management for IT-networks containing medical devices – Part 1: Tasks, responsibilities and activities“. This article reveals what the standard requires and why manufacturers should also consider it.
DetailsThe V-model is a development process model that was originally used for government projects (e.g., armaments). To this day, it is still anchored in many people’s minds and in standards for projects in regulated environments (e.g., medical technology, banks). This leads to disputes in teams that prefer agile development processes. This article helps to resolve…
DetailsLaws and standards formulate requirements on how medical device manufacturers must define and document the development process. Notified bodies check these requirements during audits. This article on the development process provides tips on how to design the process and how to align it with other processes, such as the risk management process.
Details