The Cove Business Standards Discussion Forums More Free Files Forum Discussion Thread Post Attachments Listing Cove Discussion Forums Main Page
UL - Underwriters Laboratories - Health Sciences
Go Back   The Elsmar Cove Business Systems and Standards Discussion Forums > Common Quality Assurance Processes and Tools > Consultants and Consulting
Forum Username

Elsmar Cove Forum Visitor Notice(s)

Wooden Line

What is a reasonable consulting fee for preparation of a complete traditional 510k? - Page 2


Elsmar XML RSS Feed
Elsmar Cove Forum RSS Feed

Monitor the Elsmar Forum
Sponsor Links




Courtesy Quick Links


Links that Cove visitors will find useful in your quest for knowledge:

International Standards Bodies - World Wide Standards Bodies

ASQ - American Society for Quality

International Standards Organization - ISO Standards and Information

Howard's
International Quality Services


Marcelo Antunes'
SQR Consulting, and
Medical Devices Expert Forum


Bob Doering
Bob Doering's Blogs and,
Correct SPC - Precision Machining


Ajit Basrur
Claritas Consulting, LLC


NIST's Engineering Statistics Handbook

IRCA - International Register of Certified Auditors

SAE - Society of Automotive Engineers

Quality Digest

IEST - Institute of Environmental Sciences and Technology


Some Related Topic Tags (Not all threads are Tagged)
consultants and consulting, 510(k)
Reply
 
Thread Tools Search this Thread Rate Thread Content Display Modes
  Post Number #9  
Old 10th December 2014, 03:27 PM
Wes Bucey's Avatar
Wes Bucey

 
 
Total Posts: 11,071
Re: What is a reasonable consulting fee for preparation of a complete traditional 510

There are a few more variables which contribute to rate or gross fee. Chief among them are:
Expertise and experience of the consultant (some medical device specialists of my acquaintance are "super experts" and could generate a complete 510 application which would sail through regulatory concerns in a single draft; others might need to go through numerous rewrites to feel confident in the submission) would determine the total elapsed time before delivery of a finished project. If time is a critical factor, the shorter time would deserve a substantial fee increase of the total fee.

As a consultant, I charge by the assignment, NOT by the hour. Doing a good job in short time results in happy customers, repeat business, and strong referrals. Almost always, the total fee is immaterial to the customer if the job is done right the first time.

Value of the completed project to the client/customer.
An experienced consultant would determine this by judicious questioning during the discussion concerning critical "deliverables." Probably not best to lead off with fee until the true scope and importance of the assignment is determined.

Reason an outsider is considered for the task. Why aren't the folks who actually designed and conducted the testing deemed "good enough" to write the finished 510K? (Are they looking for someone to put lipstick on the pig?)


Sponsored Links
  Post Number #10  
Old 11th December 2014, 05:57 AM
Marc's Avatar
Marc

 
 
Total Posts: 25,731
Re: What is a reasonable consulting fee for preparation of a complete traditional 510

Quote:
In Reply to Parent Post by Dramirez View Post

Marc:

I'm currently based in Montreal, Canada. The work is to be done for a large corporation, and will be for a Class II device on the Neurology panel (882.1400). Is a completely new device intended for neonatal population.

Thanks
I'm not in regulatory affairs so I personally don't know what they are charging. As others have pointed out, it depends upon the job.

For work I do I charge anywhere from US$50/hr. for small local jobs to US$1450 a day for larger jobs with larger companies. I quote each job differently using a "quote" spreadsheet I made up some years ago to approximate aspects such as travel expenses and such.

My hope here was that someone who is in regulatory affairs might be able to give some ball park figures for regulatory affairs consulting.

As an aside, while size of job and such are factors, a big factor will be who - That is, an individual will typically be less expensive than a big consulting company.
Sponsored Links

  Post Number #11  
Old 17th November 2016, 10:07 PM
Julie O

 
 
Total Posts: 221
Re: What is a reasonable consulting fee for preparation of a complete traditional 510

What kind of qualifications do you bring to the job?

What will be your relationship to the the 510(k) applicant? Are you being contracted directly, or is there a third-party in the mix?
  Post Number #12  
Old 17th November 2016, 10:34 PM
Julie O

 
 
Total Posts: 221
Re: What is a reasonable consulting fee for preparation of a complete traditional 510

Quote:
In Reply to Parent Post by Wes Bucey View Post

Why aren't the folks who actually designed and conducted the testing deemed "good enough" to write the finished 510K? (Are they looking for someone to put lipstick on the pig?)
Probably because they are engineers and this is what I call a "clinical 510(k)," as opposed to an "engineering 510(k)," which includes only engineering data. The clinical data collection was probably farmed out too, one way or another. If it was a small study, they may have put it in the hands of an MD. That can work out okay or not so well, depending on the MD. If it was a larger study, they probably had a CRO do it for them.
Reply

Lower Navigation Bar
Go Back   The Elsmar Cove Business Systems and Standards Discussion Forums > Common Quality Assurance Processes and Tools > Consultants and Consulting

Bookmarks



Visitors Currently Viewing this Thread: 1 (0 Registered Visitors (Members) and 1 Unregistered Guest Visitors)
 
Thread Tools Search this Thread
Search this Thread:

Advanced Forum Search
Display Modes Rate Thread Content
Rate Thread Content:

Forum Posting Settings
You may not post new threads
You may not post replies
You may not post attachments
You may not edit your posts

BB code is On
Emoticons are On
[IMG] code is On
HTML code is Off


Similar Discussion Threads
Discussion Thread Title Thread Starter Forum Replies Last Post or Poll Vote
A traditional 510K or Special 510K - Manufacturing facility and other changes MichelleZheng US Food and Drug Administration (FDA) 16 17th April 2014 07:45 AM
OTS (Off The Shelf) Software Validation for 510k Traditional youuu 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3 29th August 2013 09:24 AM
Charge (Fair Prices) by a Consultant for a traditional 510k Review regmeddevices Other US Medical Device Regulations 2 13th December 2011 01:22 PM
Traditional 510k Filing SOP (Standard Operating Procedure) Silvertabb 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4 1st October 2010 11:43 AM
Reasonable - Defining a Reasonable Amount of Time Close Out CPAR's Fire Girl Definitions, Acronyms, Abbreviations and Interpretations 6 8th June 2001 12:32 AM



The time now is 01:20 AM. All times are GMT -4.
Your time zone can be changed in your UserCP --> Options.


 
 


NOTE: This forum uses "Cookies"