1. This site uses cookies. By continuing to use this site, you are agreeing to our use of cookies. Learn More.
Dismiss Notice
You must be a registered member in order to post messages and view/download attached files in this forum.
Click here to register.

iso 13485

  1. Eloisa Hufana
    Thread

    Mobile Scooters Classification

    Good day! May I clarify please if mobile scooters are considered as class 1 device in Canada? Does it require an ISO 13485 certification? Thanks!
    Thread by: Eloisa Hufana, Feb 13, 2024, 2 replies, in forum: ISO 13485 and ISO 14969 – Medical Devices QMS
  2. Malius
    Thread

    Infallibility of QA department?

    I'm interested to know your experience and practices with respect to Non-Conformance reporting for incidents involving or caused by QA personnel....
    Thread by: Malius, Nov 18, 2021, 10 replies, in forum: ISO 13485 and ISO 14969 – Medical Devices QMS
  3. PoojaN
    Thread

    ISO 13485 vs CFR 820

    So I'm a new grad who was just hired as my company's QA manager. We're a small company and classified as a initial distributor since we don't have...
    Thread by: PoojaN, May 26, 2016, 4 replies, in forum: ISO 13485 and ISO 14969 – Medical Devices QMS
  4. MarkMeer
    Thread

    Does requirement to validate QMS software rule-out cloud-based apps?

    Curious: The just-released ISO 13485:2016 will require vigilance regarding validation of QMS software. I'm wondering to what degree this would...
    Thread by: MarkMeer, Feb 29, 2016, 16 replies, in forum: ISO 13485 and ISO 14969 – Medical Devices QMS
  5. Nomi P
    Thread

    Equipment SOPs

    Is there a regulatory requirement (either ISO 13485 or FDA CFR) to have a written SOP/work instruction for each piece of laboratory equipment,...
    Thread by: Nomi P, Jan 28, 2016, 1 replies, in forum: ISO 13485 and ISO 14969 – Medical Devices QMS
  6. S. Desai
    Thread

    ISO 13485 - New Facility Question

    We are medical device software company that manufactures stand alone software. Our headquarters is ISO 13485 certified and is audited annually by...
    Thread by: S. Desai, Jan 27, 2016, 2 replies, in forum: ISO 13485 and ISO 14969 – Medical Devices QMS
  7. MarkMeer
    Thread

    Notified Body Debacle

    Hoping for some advice/comments regarding our difficulty sourcing a Notified Body (NB). Here's the situation: - We're not based in the EU, but...
    Thread by: MarkMeer, Jan 25, 2016, 14 replies, in forum: EU Medical Device Regulations
  8. MarkMeer
    Thread

    What's the deal with MDSAP?

    I just got an email from Health Canada notifying me that they are transitioning from the ISO 13485/CMDCAS to the MDSAP certification program. ...I...
    Thread by: MarkMeer, Dec 11, 2015, 11 replies, in forum: ISO 13485 and ISO 14969 – Medical Devices QMS
  9. Daliane
    Thread

    Comply with GMP 21 CFR (820) / excisting ISO 9001 and ISO 13485

    Hello everybody, we are a German OEM for medical devices. One of our customer will have the US as a new target market. So we need to comply with...
    Thread by: Daliane, Oct 30, 2015, 4 replies, in forum: Medical Devices (21 CFR Part 820)
Showing results 1 to 9 of 9