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MDR Gap Analysis - Consultant fees

JoCam

Trusted Information Resource
#1
Hi All,

Before I start, I'm not asking this question because I need a MDR gap analysis performed, I did it myself. However, I am curious as to how much this activity would've cost me if I had decided to outsource.

JoCam
 
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mihzago

Trusted Information Resource
#2
It's really difficult to answer that question because there's going to be a very wide range of costs depending on the consultant (independent vs. a big consulting firm) and the type of company/product you have. Many consulting firms charge premium for MDR services because it's new and proper assessment critical; fees of $400-$500 per hour for their senior consultants would not be surprising.
 

Tobias_HF

Involved In Discussions
#3
It's really difficult to answer that question because there's going to be a very wide range of costs depending on the consultant (independent vs. a big consulting firm) and the type of company/product you have. Many consulting firms charge premium for MDR services because it's new and proper assessment critical; fees of $400-$500 per hour for their senior consultants would not be surprising.
Not a freelancer myself, but friends are and do this work: 150€ plus x for medium / long term assignments.
From my own experience I can say: its worth to book the good, expensive (and pretty rare) ones....:-(
 

Steve M

Starting to get Involved
#4
We have used a consultancy firm for parts of the MDR transition and this ranged from £100-180 per hour depending on the expertise required.
 

JoCam

Trusted Information Resource
#5
It's really difficult to answer that question because there's going to be a very wide range of costs depending on the consultant (independent vs. a big consulting firm) and the type of company/product you have. Many consulting firms charge premium for MDR services because it's new and proper assessment critical; fees of $400-$500 per hour for their senior consultants would not be surprising.
Hi Mihzago,

Thank you for the hourly fee provided. Would you know typically how long one would take to perform?

Jo
 

mihzago

Trusted Information Resource
#6
Hi Mihzago,

Thank you for the hourly fee provided. Would you know typically how long one would take to perform?

Jo
how long did it take you? Your time should be a good ballpark.
You may find a consultant that is very efficient and knowledgeable and could do it faster, but then you have in-depth knowledge of your product and company processes so you could identify gaps more efficiently.

I did a few gap assessments, but it was a few years ago and I don't remember how long it took me. Maybe 20 hours? Probably more if you include action plan to address the gaps.

The rates I mentioned ($300-400) are probably on the higher end and you could certainly find consultants (especially independent ones) with rates ranging $100-200.
 

JoCam

Trusted Information Resource
#7
how long did it take you? .
Hi mihzago,

It took me 2 days with the completion of the action plan, but I designed and implemented the quality management system and put together the design history files and technical files for the devices, so I was armed with a whole lot of insight. I was wondering how long a fresh pair of eyes would propose as a timeline for completion.

Jo
 
#8
I've been doing nothing but MDR gap assessments, GSPR's & MDR STED's and templates since 2017. Most companies have the typical gaps as with the new MDR requirements i.e. CMR, PSUR, PCMF, labelling updates, clinical, etc. so it would really depend on how organised the company documents and current MDD TF are in order to do a gap assessment and convert to MDR format. A gap assessment would also depend on familiarity with specific types of devices i.e. software, electronic, MR compatible, implant, sterile, reusable, classification, etc. I could likely complete a GSPR in 1-2 days if the docs are organised and have an up-to-date ERC. The GSPR template I use lists applicable ER's so it is easy to cross reference. I am an RA Consultant with over 19 years experience with my own LLC so I base my fees either on Project Basis i.e. flat rate for completion or an hourly rate for long and short term contracts. Please note, it takes many hours to put the templates together so for most Consultants a project rate would likely be implemented, rather than simply be charged at an hourly rate.
 
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