FTA: Fault Tree Analysis
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.
Design review not the same as review of the design!?
When asked what a design review is, you often get different answers – depending on whether you ask a developer or a quality manager. It is precisely these different views that can become a problem in the audit.
Cognitive walkthrough and usability verification
The cognitive walkthrough is one of many methods for testing the usability of products. There are many others. An overview of these methods, particularly those for validation of usability, can be found here.
DetailsDesign History File: Device Master Record, Device History Record
The 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.”
User Request and User Requirement
How do you identify the real user requirements (customer requirements)? Simple: you ask the users what their requirements are. Wrong! That won’t tell you what the user requirements are, just the user requests! This confusion can spell disaster for your project!
Harm according to ISO 14971
A 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.
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