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Which Medical Device Standard Registrar would you recommend?

Which Registrar would you recommend?

  • BSI

    Votes: 2 66.7%
  • LNE

    Votes: 0 0.0%
  • SEMKO

    Votes: 1 33.3%
  • NSAI

    Votes: 0 0.0%

  • Total voters
    3
  • Poll closed .

fcowdery

Starting to get Involved
#1
We were recently notified that our registrar no longer supports our device category.

We have 2 options for a new registrar, neither of which do I have prior experience: LNE, and BSI,

It would be helpful to our decision, if anyone can share their experiences with either registrar. (Good or Bad :D)

Tahnks in advance
 
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GStough

Staff member
Super Moderator
#2
Hello,

The only name in the list above with which I'm familiar is BSI. BSI is generally pretty good, from my experience. I have heard positive and negative from others who have used them, but my experience with them was positive.

I hope this helps.
:)
 

GStough

Staff member
Super Moderator
#4
Without specifying which standard(s) it's difficult to reply.
Hi Marc,

Medical Device Standard (in the Thread Title) would be ISO 13485, but the OP didn't say which version, nor the type/class of medical devices. This would be helpful, as well. There may also be other medical device standards out there of which I may not be aware.
 
#5
We were recently notified that our registrar no longer supports our device category.

We have 2 options for a new registrar, neither of which do I have prior experience: LNE, and BSI,

It would be helpful to our decision, if anyone can share their experiences with either registrar. (Good or Bad :D)

Tahnks in advance
Assuming you're looking for an MDD Notified Body, you can search by device category on the Nando site. Search "EU Nando". Sorry, I'm not able to post the specific URL.
 
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