Articles
Know about Medical Device Technical File
by Arianna Lane marketing headTechnical File or Technical
documentation has to be developed before applying to Notified Bodies
Technical
File or technical documentation should be well organized and presented in
such a way to easily understood by third person reviewer to facility speed
processing of technical file review.
As per MDR 2017 Technical File or
technical documentation should be made covering all the requirements in clear
and legitimate way covering risk analysis, clinical evaluation and the general
requirements for safety and performance.
Content of the
Technical File / Technical Documentation are the following
Device description
and specification
UDI)
Classification
DOC
Description of the principles of operation of the device and
its mode of action
Summary of safety and clinical performance
Declaration on
particular substances:
Previous and similar generations
Labelling / instructions for use
Design and manufacturing information
Description of the manufacturing
General Safety and Performance Requirements
Benefit-risk analysis and risk management
Product verification and validation
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About Arianna Lane 
marketing head
54 connections, 3 recommendations, 203 honor points.Joined APSense since, February 22nd, 2019, From Utah, United States.
Created on Oct 21st 2019 11:40. Viewed 368 times.
