V-model: Avoiding the 5 most common problems

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…

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Development plan versus development process

Medical 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…

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Development process: Lean and compliant with standards

Laws 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. 1. Development process:…

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Develop software components compliant with IEC 62304 and FDA

Medical 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. 1. What software components / items are There are different definitions of “software component”, also referred to as software items as…

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Clinical endpoints: Why they are important

When 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. 1. Clinical endpoints: The basics…

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Functional safety of medical devices

Medical 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. 1. Functional safety: The background a) Who has to deal with it? The following roles must understand the concepts of functional safety:…

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