Expedited, fast-track Notified Body Technical File reviews

Sam Lazzara

Trusted Information Resource
#1
Any experience with paying for expedited (fast-track, real-time, etc.) reviews offered by some Notified Bodies?

I see that BSI and TUV SUD appear to offer such expedited reviews. Any experience with them or other NBs?

BSI CE-Dedicated FastTrack
The CE-Dedicated FastTrack review service allows you to book your technical documentation review in advance. The service is conducted remotely with your BSI Product Expert, who uses the time allocated to your company to conduct a focused review of your technical documentation. This allows you to interact with your BSI expert, providing them information during the review. The CE-Dedicated FastTrack service improves the efficiency of the process, and provides predictability in your planning of the review.

BSI CE-Onsite FastTrack
The CE-Onsite FastTrack review service is conducted at your premises; a BSI Product Expert visits the facility for a period of time. CE-Onsite FastTrack reviews allow for dynamic communications and opportunities for immediate responses to questions raised by the reviewer. Planning a CE-Onsite FastTrack review in advance provides you with more predictability and the reassurance of knowing when your BSI Product Expert will be at your premises.

TUV SUD Info
 
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SteveK

Trusted Information Resource
#2
Forget about fast track - my experience with BSI (UK) basic TF audits (three days for two tf files), plus minder was absolute crap. Youngsters who knew it all (not1). Questioning 30 years of medical device experience to their none existence knowledge. Total sh*t heads.

SK
 

lewisking34

Starting to get Involved
#3
I haven't dealt with any Fast Track services before, but FYI...

I know that due to the current backlog in audits, some NBs (inc. BSI) are only providing a Fast Track service at the moment. Who knows how long this restriction will last. But if you want a technical file assessed sooner rather than later it seems like its the only option (with BSI anyway).
 

pkost

Trusted Information Resource
#4
I think fast track is just another term for "level of service you would expect" at a significant markup for the slow/non existent service level that is normally provided

I appreciate they have a high workload and pressures, but their processes don't help (which is somewhat ironic). Why can't I easily contact my assessor? Why document issues that then require my formal response when the answer is already in the documentation provided and could be easily resolved by then giving me a call?
 
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