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💡 The Medical Device Coordination Group has published the MDCG 2019-15 guidance for manufacturers of Class I medical devices. The MDCG recommends the establishement of a quality management system that includes:- A strategy for regulatory compli...
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Category: Quality assurance
The obligations of distributors of medical devices
The obligations of distributors of medical devices are stated in the art. 14 of the MDR Regulation (EU) 2017/745. Distributors must: ☑️ Verify the devices and the documents provided before placing them on the market ☑️ Keep a record o...
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Do you know that our RA/QA department offers courses? With Askorn you can train yourself to Quality Management. Quality Management TrainingTélécharger Please see our courses catalogue here → https://lnkd.in/eaVZtJ2 For more informat...
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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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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 ...
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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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