Cost to obtain ISO 13485 Certification/Registration from Start-up

P

potato124

#1
Hello,
I am interested in understanding the time and expense associated with obtaining a medical device ISO cert for manufacturing, literally from the ground up. We are a startup, have obtained a manufacturing space, and want to get to manufacturing as soon as possible. We have a skeleton design control system that will need improvement.

How long will it take?
How expensive would it be?

Any advice or reading material associated with this would be appreciated...

Thanks,
Mitchell
 
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Kales Veggie

People: The Vital Few
#3
Welcome,

(you will here this often).. that depends.

Registration to ISO13485 by an accredited registrar for a small company would be between 5k and 10k (very rough numbers). This is the cost paid to the registrar only.

It depends how much you want to do yourself, what experience and what skills you have in-house and how much time you have available. If all of you are very busy, consider hiring a project manager on a part-time basis.

I am currently involved with a small medical device company where I am part-time and my task is to get the company registered to ISO13485 and build systems/processes for this growing company.

If you would like more information, please contact me (see my user cp or my linkedin profile)
 
#4
To assist you with the CB side of life, I can give you a cost for an accredited registration to ISO 13485, if you'd like.....
 
D

diagmgr25

#5
I am also interested in ballpark costs for ISO 13485.

We are in the Foxboro MA area - any have recommendations for a registrar?
Thanks:thanx:
 
J

JCVP1969

#6
That is a how long is a piece of string kind of question!

It does depend on the Registrar but all have guidlines that allocate a certain number of days / hours using a risk based approach. That usually means they take a look at the number of premises, number of employees, type of industry sector, the type of product you are making, if you do design and also how many of your staff are doing the same kind of role.

I am not a Registrar but as a consultant working in the USA and quite often having to book these Assessments, I would say $3,000.00, but that is a guess as I do not have much information to work on! I am sorry to disagree with anyone but I would say 5-10 would be rather expensive unless you are using an Uber expensive Registrar!

In terms of other implementation costs that does depend on the amount of work you are able to do yourselves. Consultants in the USA tend to charge more than in the UK, so I would say $8,000.00 for a UK based one and $10-15K for a consultant based in the USA (I may be wrong with that pricing).

Apologies for all I have offended!

Jonathan
 
Last edited by a moderator:
Q

Qualqueen

#8
Any advice or reading material associated with this would be appreciated...

Thanks,
Mitchell
Are you planning on only manufacturing medical devices? If not, ISO9001 would seem more logical or you could get a duel certification for 9001 and 13485 as we did. They're very similar to a certain degree. The best thing would to be to get a copy of 13485:2003. The annex in the back of the book explains the differences between the two. Good luck!! :bigwave:
 
J

JCVP1969

#9
I have no idea really regarding the prices, I think there is generally more demand in the USA and also the market expects to pay more.

Also the approach is slightly different on either side of the pond. There is greater emphasis on process validation with the FDA.
 

Kales Veggie

People: The Vital Few
#10
I am also interested in ballpark costs for ISO 13485.

We are in the Foxboro MA area - any have recommendations for a registrar?
Thanks:thanx:
I would contact different registrars (they advertise on the board, see left side and top). Get a quote, get references, interview them and find the best one for your company.
 
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