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:
- Consulting fees
- 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).