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Start-Up Company looking for ISO 13485 Certification Body and Medical Device CE Mark Notified Body

#1
Greetings all,

I am a Quality Assurance / Regulatory Affairs Manager at a Start-up in California. We are trying to get an ISO 13485 audit scheduled with BSI as well as a Technical File (or Documentation) review some time this year. Unfortunately they are refusing new customers. They don't want to perform stand-alone audits, as they no longer do MDD Technical File reviews, and are not legally allowed to schedule for MDR Technical Documentation reviews.

Is anyone having similar experience and do you have any recommendations?

I have already started contacting some backup registrars / notified bodies, but I am seeing a lot of the same issues. (TUV SUD, TUV Rheinland)

Matthew
 

yodon

Staff member
Super Moderator
#2
Yeah, you're in a weird place. On one hand, it's good BSI refused, knowing that they don't have resources to support you. Reviews across the board are taking a very long time (so it's not just BSI that's swamped).

The only recommendation is to keep looking for a NB that will take you on. Be sure they are accredited and plan to at least file for designation under the MDR.
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#3
Unfortunately they are refusing new customers.
Welcome to The Cove. This issue has been discussed a number of times here. In most cases, the most well known ISO 13485 CB's are also Notified Bodies for Medical Devices. These organizations are under severe pressure from the competent authorities and subjected to increased oversight. Most of them are scrambling for resources and your situation is not unique.

It seems to me that, due to some high profile ethical breaches, the French PIP scandal being one of the most public ones, many CB's/NB's are uncertain about the legal risks they face and don't want to expand their business much bigger than what they have now. A multi-billion dollar/euro penalty would wipe out any of these organizations.

Good luck.
 

mihzago

Quite Involved in Discussions
#4
BSI is not being very responsive. I've been asking them to schedule MDSAP audit for two years now to no avail.
Someone recently had luck with Intertek so you could try them.
 
#5
Thank you for the feedback. In talking to the notified bodies I have heard nothing but bad things about MDSAP. At my previous company we went through an MDSAP audit and it was a nightmare. 8 months after the audit still waiting for them to formerly close the audit and give us the certification. I can understand if the notified bodies don't want to perform MDSAP anymore.
 
#6
Greetings all,

I am a Quality Assurance / Regulatory Affairs Manager at a Start-up in California. We are trying to get an ISO 13485 audit scheduled with BSI as well as a Technical File (or Documentation) review some time this year. Unfortunately they are refusing new customers. They don't want to perform stand-alone audits, as they no longer do MDD Technical File reviews, and are not legally allowed to schedule for MDR Technical Documentation reviews.

Is anyone having similar experience and do you have any recommendations?

I have already started contacting some backup registrars / notified bodies, but I am seeing a lot of the same issues. (TUV SUD, TUV Rheinland)

Matthew
Hi Matthew,

since you mentioned that you are contacting some backup notified bodies, maybe you want to try with ECM?
I was recently approached by their Account Manager on LinkedIn, he was promoting their services and mentioned that they are open to new customers. My company doesn't need it, but it might help someone else.
I checked, ECM (no. 1282) is both the NB for CE marking as well as ISO 13485 certification body.
 

PearlKetchup

Starting to get Involved
#7
My (startup) company uses LNE/G-MED and I've enjoyed working with them so far. You might try reaching out to them? My company had been customer for a few years before I joined so a good working relationship has already been established. It seems that they are handling the MDD/MDR transition well and from my interactions with our project manager there I recommend them.
 

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