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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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EU MD Regulation : the race to compliance
In a survey published by KPMG and the RASP (Regulatory Affairs Professional Society), more than 200 Quality and Regulatory Affairs managers were asked how prepared they feel regarding the coming EU MD Regulation. The companies that took part in the s...
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 ...
Lire la suiteObligations of medical devices distributors
The MDR 2017/745 also impacts medical devices distributors, whose obligations and responsabilities grow. Distributors are now expected to verify the conformity of the products they place on European market, through the following documentary verti...
Lire la suiteMD 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...
Lire la suiteNotification of bodies for new MD regulations
The european association of notified bodies for medical devices Team-NB published the list of member bodies that intend to submit an application to be designated against the new regulations. With no surprise, all 23 members of the association in...
Lire la suiteAskorn at Medtec Ireland
Askorn is attending the Medtec event in Galway, Ireland, the 4th and 5th of October at the Radisson Blu Hotel. Medtec brings together over 900 Medical Device professionals from various countries around the world. The exhibition serves not only ...
Lire la suiteTeam NB : 2016 survey results
On May 9, 2017, the European Association for Medical Devices of Notified Bodies Team-NB published the results of its yearly survey run among its 21 members, in order to collect data on certificate emission and analyse the variation with previous yea...
Lire la suiteNetherlands : UDI for implantable MD from July 1st, 2018
On June 21, 2017, the Dutch minister of health signed an agreement with healthcare profesionnals and manufacturers in order to introduce an identification system for medical devices. It was agreed to adopt the FDA's UDI (Unique Device Identificat...
Lire la suiteAccess to French market: Summary of Medical Device Characteristics to provide to the ANSM
Article 147 from French law n° 2016-41 dated January 26th 2016 relating to the modernization of the French healthcare system specifies that when a medical device is first put into service on the French national territory, the manufacturer or its aut...
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