Average Cost of ISO 13485 Registration in US

S

slowellh

#1
Hello all. I have been looking for that average cost of 13485 consultation and registration for a couple of hours and it has come to naught.

I am starting the process of 13485 and am collecting quotes. My boss thinks that the prices are crazy-a 15k estimate just for consultation. So my question to the forum members here is: What can I expect for basic costs? We have 1 product and 5 employees. It is a Class 1 devices with CB and UL 60601 certifications. I can provide more information if necessary.

Thanks
 
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DannyK

Trusted Information Resource
#2
Hi

As a consultant and auditor for medical devices, it seems like the $15,000 consultation is a little high. Assuming that you already have certain controls and that you are looking into a simple quality management system, it should not cost more than $10000.

Are you getting ISO 13485 with CMDCAS and CE marking?
The CE marking part will add a few extra procedures and add to the cost.

For a company of your size, I have seen quotes for about $6000 for 3 years from registrars for just ISO 13485.

If you require more information, please contact me through a personal message.

Danny
 

harry

Super Moderator
#3
Hello all. I have been looking for that average cost of 13485 consultation and registration for a couple of hours and it has come to naught. ..................................
Welcome Slowellh,

Just a reminder - you may reach the private messaging (PM) or email function for any user by clicking on their respective user-name or screen-name.
 

Ajit Basrur

Staff member
Admin
#4
Hello all. I have been looking for that average cost of 13485 consultation and registration for a couple of hours and it has come to naught.

I am starting the process of 13485 and am collecting quotes. My boss thinks that the prices are crazy-a 15k estimate just for consultation. So my question to the forum members here is: What can I expect for basic costs? We have 1 product and 5 employees. It is a Class 1 devices with CB and UL 60601 certifications. I can provide more information if necessary.

Thanks
Hi slowellh,

Welcome to the Cove :bigwave:

Unfortuantely, I can not comment as I do not know the rates in US. You could contact Danny and also wait for more responses from the Cove.
 
S

slowellh

#5
A little bit more about that 15k quote-It does include all travel expenses (3x) from the consultant to our location and a guarantee that the consultation will not exceed this amount. It also specifies estimated hours, etc.

We have self declared CE (again we are Class 1, non-invasive). We do spec development and are a contract manufacturer, but we may move manufacturing to our location (currently overseas).
 

yodon

Staff member
Super Moderator
#6
Just be careful that you're not being sold a "package" that won't meet your needs. We had one client that hired a consultant to set them up with a system so they could pass an FDA audit. They were (are) a small company (not as small as yours) and the consultants basically dumped a package on them that was more suitable for a Johnson & Johnson. I read one SOP that called for more committees than they had employees!

So while I can't comment on the cost, I can hopefully give you a heads-up on something to look out for. Be sure they understand your business model and will ensure the system is right for you.
 

Stijloor

Staff member
Super Moderator
#8
Friends,

I noticed that there are different responses in this thread with regard to "charges." For the purpose of budgeting, please keep in mind that there are two types of charges or fees to be considered:
  1. Consulting fees
  2. Certification Body/Registrar fees.
Stijloor.
 

Ajit Basrur

Staff member
Admin
#9
The split up is usually for these main categories -

Certification Assessment that will include main audit and some registrars may charge application fee

Surveillance Assessment for the annual audits.
 
R

Roland Cooke

#10
Friends,

I noticed that there are different responses in this thread with regard to "charges." For the purpose of budgeting, please keep in mind that there are two types of charges or fees to be considered:
  1. Consulting fees
  2. Certification Body/Registrar fees.
Stijloor.

slowellh said:
Hello all. I have been looking for that average cost of 13485 consultation and registration for a couple of hours and it has come to naught.

I am starting the process of 13485 and am collecting quotes. My boss thinks that the prices are crazy-a 15k estimate just for consultation. So my question to the forum members here is: What can I expect for basic costs? We have 1 product and 5 employees. It is a Class 1 devices with CB and UL 60601 certifications. I can provide more information if necessary.

Thanks

As Stiljoor points out, there are two completely different costs involved here.

The first is the cost of getting an ISO13485-compliant quality system into place, and fully implemented. If you can do that yourself, great.

If not you will likely have to hire a QA/RA consultant who will spend some days/weeks helping to achieve this. As has been warned above, be very careful about accepting something that will simply be parachuted in.

If you can scratch the name of your company out, and write John Doe Medical instead, it will probably be too generic - at least in some places - for your needs.

So for this element you do need to talk to some consultants, (there is a separate forum in the Cove, even). Really make sure you understand exactly what it is you need, and what each consultant can offer. Only then should you get some quotes.
Go for the one that makes you feel the most comfortable, whilst not sending you bankrupt!


At the same time, you will need to prepare for third-party certification. That is an additional cost, charged by a completely different organisation (such as my own).
For a small company, that would typically somewhere between 5-10,000USD (lots of things can affect the price) for the first year, probably around a third of that annually from then (again, lots of variables here).
 
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