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iso13485

  1. Francesco.l
    Thread

    USB-IF standard includes also ISO13485

    Hi all, we are design a portable biomedical device. We need to provide also a charging cable with ubs type c to type A. The first requirements is...
    Thread by: Francesco.l, Apr 30, 2021, 1 replies, in forum: ISO 13485 and ISO 14969 – Medical Devices QMS
  2. ValeriaGar
    Thread

    What do you think about Remote Audit during COVID 19?

    Due to the current situation, we all switched to remote work, audit, etc. How effective do you think this way of auditing is? We know that the...
    Thread by: ValeriaGar, Dec 22, 2020, 6 replies, in forum: ISO 13485 and ISO 14969 – Medical Devices QMS
  3. Luca Ercolani
    Thread

    Adobe Sign as digital signature tool

    Hi all, This is my first post here, so I apologize if this is the wrong section. I'm building a Quality Management System for a young European...
    Thread by: Luca Ercolani, Jun 8, 2020, 2 replies, in forum: ISO 13485 and ISO 14969 – Medical Devices QMS
  4. Karly Chester Etzel
    Thread

    Design and Development Plan

    Just wondering what resources people used to create their design and development plan template. We have a project charter, but my understanding is...
    Thread by: Karly Chester Etzel, Sep 25, 2018, 4 replies, in forum: ISO 13485 and ISO 14969 – Medical Devices QMS
  5. Karly Chester Etzel
    Thread

    Document Record Numbers

    I'm working to transfer all of our paper documents into electronic copies managed in our EQS. We're currently working with ISO13485 and 21CFR 820...
    Thread by: Karly Chester Etzel, Aug 21, 2018, 5 replies, in forum: Documentation Control, Procedures, Templates,...
  6. Jonathan Wilkie
    Thread

    NB's auditing practice called into question...

    I am an engineer for a small (<50 employees) medical device manufacturing plant. I am currently working on an R&D project that will be ultimately...
    Thread by: Jonathan Wilkie, Jan 19, 2016, 4 replies, in forum: ISO 13485 and ISO 14969 – Medical Devices QMS
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