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Where to start with ISO 13485 and Registrars near Seattle

X

xp2007

#1
Dear all,
Are there any good register agent for ISO 13485 nearl Seattle area? We never filed FDA or ISO before. How do I get start? We were OEM manufacture and have some basic SOP and QC procedures for our products. Thanks.
 
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R

Roland Cooke

#2
Re: Iso13485

You need a few things:

1) First you need to be (reasonably) clear what your company will be doing, in what countries it will be doing those things, and what the regulatory responsibilities come with that.
(For example it makes a difference if you will be relabelling someone else's knee-reflex tapper for sale in the USA; as compared to if you will be responsible for designing, manufacturing and selling a novel heart pacemaker into Japan).

2) Second, you sound as if you will need a consultant to evaluate the completeness of your current system and to help you build the rest of it. You should ensure that the consultant you hire can also assist you to understand the items in point 1 if you so require.
Depending on how much work you need, there will be an advantage in having a local consultant, to save costs. But be careful. You need the right consultant, not necessarily the cheapest / most local.

3) A third-party certification body (if required). This body can provide ISO13485 registration. There are quite a few of these organisations, but note that the list of such bodies narrows if you intend to sell to Canada, Europe, Japan, etc etc.
It won't make much difference if the organisation is local or not. (We have a client in the same office block as us, and we routinely fly in an expert from out of state to perform some specialised aspects of the audit process! (I do the "easy" bits!)
Again, spend your money carefully, do some homework here.


Note: You don't need ISO13485 if you only intend to sell in the USA (but there is an argument that it is nonetheless a useful thing to implement).
 
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