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…
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. Step 1: Define the business case a) Determine the intended purpose of the DiGA The intended purpose is the basis for all further steps.…
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. 1. Functional safety: The background a) Who has to deal with it? The following roles must understand the concepts of functional safety:…
DetailsThe probability of software defects is difficult to estimate. It’s so difficult that the “old” DIN EN IEC 62304:2006 wrote: “However, there is no agreement on how to determine the probability of the occurrence of software failures using traditional statistical methods.” The standard concluded that “the probability of such a malfunction must be assumed to…
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