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Post# E537857

01 Jan, 26
Medical device technical file

Posted on: Saturday, 24 January, 2026  09:48
Updated On: Saturday, 24 January, 2026  09:51
Expires On: Friday, 20 October, 2028  15:48
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A medical device technical file contains essential documentation proving a device's safety, performance, and regulatory compliance. It includes product descriptions, risk assessments, design data, test reports, labeling, and instructions for use. This file is mandatory for regulatory approvals like CE marking under EU MDR or other international standards.
http://www.i3cglobal.uk/technical-file-medical-device/ »

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