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We are pleased to announce that our company has obtained EU conformity certification for our reusable surgical instruments in accordance with Regulation (EU) 2017/745. This major milestone confirms the quality, safety, and compliance of our produc...
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Category: Quality assurance
ISO 13485:2016 certification renewal
ASKORN's ISO 13485:2016 certificate was successfully renewed under the scope "Design, manufacturing and sales of implantable medical devices and instruments for orthopaedic surgery" by the French notified body GMED. This recognition reflects our o...
Lire la suiteGuidance for manufacturers of Class I medical devices
💡 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...
Lire la suiteThe 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...
Lire la suiteQuality Management Training
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...
Lire la suiteISO 13485 certification, 2016 version
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...
Lire la suiteUS 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 ...
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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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