• EnglishEnglish
    • FrançaisFrançais
    • EnglishEnglish
    • Breton
  • Home
  • Presentation
  • Our expertise
  • Our achievements
  • News
  • Contact us
  • Français
  • English
    • Askorn
    • EnglishEnglish
      • FrançaisFrançais
      • EnglishEnglish
      • Breton
    • Home
    • Presentation
    • Our expertise
    • Our achievements
    • News
    • Contact us

    Actualités

    Category: Quality assurance

    Publié le 26/10/2018 - Announcement, Quality assurance, Regulatory affairs

    ISO 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 suite

    Publié le 22/06/2018 - Quality assurance, Regulatory affairs

    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 ...

    Lire la suite

    Publié le 08/12/2017 - Quality assurance

    MD 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 suite

    Catégories

    • Announcement
    • Events
    • Non classé
    • Quality assurance
    • Regulatory affairs

    Recent posts

    • New service – UK responsible person
    • Covid 19 – continuity of our services
    • Askorn on local Britanny TV programme
    • ISO 13485 : 2016 certificate renewal
    • ISO 13485 certification, 2016 version

    À la une

    Publié le 18/02/2021

    New service – UK responsible person

    As part of the news encompassing Brexit, French manufacturers wishing to place medical devices to the Great Britain market must appoint a UK responsible person. Askorn offers a solution of UK responsible person and ensures for you the registration of your medical devices with the MHRA and manages requests from the MHRA. Contact us for further information on t...

    Lire la suite

    Copyright © 2021 Askorn. Mentions légales - Réalisé par Imagic.

    Nous utilisons des cookies pour vous garantir la meilleure expérience sur notre site. Si vous continuez à utiliser ce dernier, nous considérerons que vous acceptez l'utilisation des cookies.Ok