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      • And more…
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      • Quality management system as a service
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      • Performance evaluation of IVDs
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      • Human Factors / Usability (IEC 62366 and FDA)
      • FDA relevant documents
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2014


User Request and User Requirement

By Dr. Philipp SchleerNovember 6, 2014Leave a comment

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

By Christian RosenzweigOctober 1, 2014Leave a comment

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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