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The quality management system developped by Askorn has been accepted as complying with the requirements of the 2016 version of ISO 13485 by the french notified body GMED. This is the first step towards MDR 2017/745 compliance. The scope of the cer...
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Category: Quality assurance
US market access : the FDA may replace QSR with ISO 13485:2016
The Food and Drug Administration is considering replacing their actual Quality System Requirements (QSR) from 21CFR part 820 with the requirements from ISO 13485 version 2016. This is for the moment a proposition of rule modification, which should ...
Read moreMD additive manufacturing : FDA guidance
The FDA published on December 5th the final issue of the guidance document "Technical Considerations for Additive Manufactured Medical Devices", dedicated to manufacturers intending to exploit this new process. This 31 pages document details th...
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