Many medical device manufacturers create a “software FMEA.” However, there is no uniform understanding of what a software FMEA is. This article provides clarity and tips on how to avoid the most common mistakes.
DetailsWhether risk mitigation through information is permitted regularly leads to discussions. The answer to this question is important because it determines the conformity and non-conformity of medical devices. This article provides the answer and thus resolves a “historical misunderstanding.”
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…
DetailsMedical device manufacturers are obliged to both describe the development process and create a development plan. Because both documents specify how medical devices will be developed, there is uncertainty as to which information belongs in which document. This article resolves this and also examines the software. It looks at the software development plan and the…
DetailsSince May 25, 2017, the In Vitro Diagnostic Medical Device Regulation (IVDR) has been in force, which has now replaced the previous IVD Directive (98/79/EC, IVDD). There are significant differences between the IVDR and IVDD. This article presents these differences. In doing so, it provides manufacturers who placed their devices under the EU directive (IVDD)…
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.
DetailsMedical software manufacturers must meet the legal requirements for software components in order to “approve” their devices. This article presents these requirements and gives seven tips on how to fulfill them quickly and easily.
DetailsThis article identifies the seven most common risk management errors that Johner Institute and its auditors encounter most often. It also offers advice on how to avoid these errors. Risk management is among the most important requirements medical device manufacturers must meet. Therefore, it is important that they avoid risk management errors.
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