Which Medical Device Standard Registrar would you recommend?

[fcowdery]

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 )

Tahnks in advance

 

[GStough]

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.

 

[Marc]

<snip> It would be helpful to our decision, if anyone can share their experiences with either registrar. (Good or Bad

Without specifying which standard(s) it's difficult to reply.

 

[GStough]

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.

 

[DSurber]

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 )

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.

 

[CharlieUK]

List of MDD Notified Bodies is
EUROPA - European Commission - Growth - Regulatory policy - NANDO

I've not worked directly with them, but couple of companies I work with use SGS in the UK.