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Regulatory knowledge for medical devices
Articles on the development and approval of medical devices and other regulatory topics
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Expert knowledge of medical device regulation

For manufacturers, authorities, and notified bodies

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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User Request and User Requirement

Usability & IEC 62366-1By 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

Risk Management & ISO 14971By 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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