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MDSAP Registrar

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

  1. Lindy

    Lindy Member

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    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

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    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

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    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

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    It might be worth trying TUV in the NE (USA). I've heard good things about them.
     
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  5. Kymberly

    Kymberly New Member

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    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.
     

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