Discover new articles every week on the topics of regulatory affairs (including international approval and FDA approval), QM systems (e.g., ISO 13485), risk management (ISO 14971), software development (IEC 62304), IT security, clinical evaluation, usability engineering (IEC 62366-1), and systems engineering (including IEC 60601-1, ISO 10993) - also for IVD medical devices.
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The 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.
DetailsAnytime you want to launch a medical device on the market, you quickly come to the question of which legal regulations you have to comply with. This article will give you answers and present the seven steps to quickly place your devices on the market in compliance with the law.
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.
DetailsWhen notified bodies identify discrepancies in clinical evaluations, in many cases, these relate to the clinical endpoints. It is, therefore, essential for medical device manufacturers to specify the clinical endpoints precisely and to demonstrate that they have actually been achieved. This article explains what manufacturers should pay particular attention to.
DetailsSince 2020, the German legislature has allowed the reimbursement of digital health applications (DiGA). DiGA manufacturers must fulfill several requirements for this. This article describes the steps required to do so.
DetailsMedical devices must comply with the legal requirements for functional safety. Unfortunately, the relevant standards and laws for medical devices do not define or use the term “functional safety.” This article provides clarity.
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