Charge (Fair Prices) by a Consultant for a traditional 510k Review

R

regmeddevices

Hi All!!

I need your help here. We are hiring an independent consultant for our 510k. Some 510k are prepared by our team and some are going to be prepared by the consultant.
I wanted to know what are the fair prices for following kinds of jobs:

1. Review of traditional 510k of Class II done by the consultant and our team prepares it completely. Consultant stays for review, correction, help until our device receives 510k.

2. Traditional 510k of Class II written, edited and reviewed by consultant. Consultant stays for review, correction, help until our device receives 510k.

All the consultants and experts here please suggest!

Thank you!!
 

sagai

Quite Involved in Discussions
Re: Charge by a consultant for a traditional 510k review

Hi,
in Hungary (!) I had 500 - 600 EUR + VAT daily fee (8hours per day) 2-5 years ago, recently due to economical climate change it could be different.
I would consider to apply for the third party review program in case it is exist for your device and have consulting from that reviewer body with payment term condition ;) .
Regards
Szabolcs
 
Last edited:

RA Guy

Involved In Discussions
Sorry I can't help with the going rate for a decent consultant, but I will give some free advice and tell you that you should also focus on selection/qualifiaction.

Saving money on a per diem can also result in significant costs in delay to market, requests for information, etc. that can result from a deficient submission.

I have had mixed results with consultants. The reality is that anyone can claim to be an expert in preparing submissions. Ideally, the person you hire should have some knowledge or backround in the type of device(s) you make. If they are any good, there should be companies ready to give them a good reference and verify their claimed track record on successful submissions.

Also I would recommend for scenario #1 (you write, consultant reviews) that you bring the consultant in early to assess your approach, etc. if possible. Rewrites of a flawed first draft are more expensive than identifying issues in planning. The need for this may depend on your organizations internal experience with 510(k)s. If you are looking for feedback on test plans, statistical plans, etc., early involvement is critical.

If it were me, I would be far more focused on quality over cost as the first criteria for selecting a consultant.

Good luck !
RA Guy
 
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