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.

MDSAP Registrar

Discussion in 'ISO 13485 and ISO 14969 – Medical Devices QMS' started by Lindy, Jan 18, 2019.

  1. Lindy

    Lindy Member

    Joined:
    Jan 10, 2018
    Messages:
    14
    Likes Received:
    2
    Trophy Points:
    2
    Hi everyone,

    My company is ISO 13485:2016 MDSAP certified as well as ISO 9001:2015 certified (some of our industrial customers don't understand that ISO 13485 is a more strict QMS and won't accept our ISO 13485 MDSAP certificate. They want to ISO 9001 certificate).

    Our registrar, NSF, just sent out an email stating that they are removing themselves as an MDSAP registrar, therefore we need to obtain a new MDSAP registrar quickly. We also want to use the same registrar for ISO 9001:2015 since it's easier for our company to just use one registrar for both.

    Does anybody have any recommendations for what registrar you have liked working with? We are located in Ohio, so those registrars that have people nearby would be helpful so we aren't paying a ton of money on travel fees.

    Thank you for any advice you can give!

    -Lindy
     
  2. yodon

    yodon Well-Known Member

    Joined:
    Aug 3, 2015
    Messages:
    198
    Likes Received:
    115
    Trophy Points:
    42
    Sorry to say, but you may be in a pretty tough spot. I've heard that several of the bigger organizations aren't even accepting new customers for MDSAP.
     
  3. Lindy

    Lindy Member

    Joined:
    Jan 10, 2018
    Messages:
    14
    Likes Received:
    2
    Trophy Points:
    2
    Yea, that's the issue I'm running into right now. With so many new standards requiring recertification this year, as well as the Brexit suspense, I'm having a difficult time even getting a quote from registrars.

    What's life without a little freak out and scramble?
     
  4. Andy Nichols

    Andy Nichols Moderator Staff Member

    Joined:
    Jul 30, 2015
    Messages:
    5,086
    Likes Received:
    2,553
    Trophy Points:
    112
    Location:
    In the "Rust Belt"
    It might be worth trying TUV in the NE (USA). I've heard good things about them.
     
    Lindy likes this.
  5. Kymberly

    Kymberly New Member

    Joined:
    May 2, 2020
    Messages:
    2
    Likes Received:
    0
    Trophy Points:
    1
    We've used BSI for a long time and have been happy. Right now they're doing Remote audits, so travel isn't an issue, I suppose. They do our MDSAP and our 9001 certification. It has been a little tough hearing back from them as IVDR and MDR are also flaming hot right now. You might keep bumping them or try contacting them through their website.