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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Black box testing is when test cases are derived solely from the specification of the object to be tested (product, component). White box testing, on the other hand, derives the test cases from the internal structure of the object, e.g., from its source code or software architecture. Unfortunately, many medical device manufacturers neither specify the test…
DetailsMany people ask about the liability of individuals, management, and the company. After all, it is not only the Medical Devices Regulations that impose fines and imprisonment. The question of liability also arises for development service providers. Liability in Germany: Differentiating between criminal and civil law Civil law: Parties involved In civil law, the question…
DetailsFault Tree Analysis is a procedure used to search for unknown causes of known effects (in the case of medical devices, harms or hazards). It, therefore, counts as a top-down procedure in risk analysis. Fault Tree Analysis: Notation The name Fault Tree Analysis already clarifies how it is represented graphically: As a tree. Both mind…
DetailsThe system architecture describes how a (medical) device is composed of components and how the components are related to each other via interfaces. In standalone software system architecture and software architecture fall together. Documentation of the system architecture The documentation should reveal the individual components and their interaction. We recommend that you use standard notations…
DetailsThe FDA requires a Design History File DHF in 21 CFR Part 820 (these are the “Quality System Regulations”). DHF should not be confused with the Device History Record DHR or the Device Master Record DMR. This article explains what the Design History File must contain and how it differs from the other two “files.” Design History File The FDA requires…
DetailsISO 14971 defines harm as “injury or damage to the health of people, or damage to property or the environment”. According to ISO 14971, the harms are usually impairments of body structure (e.g., cut) or body function (e.g., ability to move, ability to see, capability to cleanse blood). To assess the risks, we must know…
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