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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Fault 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…
DetailsA medical device can cause harm to patients, users, or third parties. The manufacturer must identify this harm to determine the device’s risks and control them. This article provides guidance on how to determine and document harm in accordance with ISO 14971 and how to use the term “harm” correctly. 1. Definition ISO 14971 defines…
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