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california, consultants and consulting, iso 13485 - medical device qms, medical device software, san jose, software development, small companies (small businesses), software company or industry, medical devices (general)
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Old 26th August 2010, 05:31 PM
tsusanto tsusanto is offline
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Look! Need consultant help for ISO 13485 Certification - San Jose, CA, USA

Hi,

We are a very small 4 employee software development company that wants to become ISO 13485 certified so that we can develop software for a medical device project. We are based in san jose, and being a start up, can't really afford huge consulting fees. Can any consultant help us? Please do send us an email describing your experience. Thanks!

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Old 26th August 2010, 06:52 PM
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Re: Need consultant help for becoming ISO 13485 certified

I am sure someone will respond to your request that specialize in Software and FDA requirements. Just be patient.

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Old 26th August 2010, 08:59 PM
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Re: Need consultant help for ISO 13485 Certification - San Jose, CA, USA

Quote:
In Reply to Parent Post by tsusanto View Post

Hi,

We are a very small 4 employee software development company that wants to become ISO 13485 certified so that we can develop software for a medical device project. We are based in san jose, and being a start up, can't really afford huge consulting fees. Can any consultant help us? Please do send us an email describing your experience. Thanks!
FWIW:
Everyone's idea of "huge consulting fees" is relative.

Before choking on a consultant's quote, consider the soft costs of proceeding WITHOUT the advice - running up blind alleys can be pretty tiring and expensive.

Also, consider negotiating with a competent consultant about structuring the fee payment in stages, even in partial equity. A consultant is different from a third party auditor, he CAN [and should] be your advocate, even to the point of sharing in your profits and losses.

As I say, everything is relative, according to the real value you derive from the relationship. Do not make your consultant selection based on price alone!

As preparation for your selection process, I suggest you read through a thread intended for existing and prospective consultants, which may give you some insight into selection. Consulting Is it in YOUR Career Future?

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Old 26th August 2010, 09:43 PM
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Re: Need consultant help for ISO 13485 Certification - San Jose, CA, USA

For a start-up on a tight budget, there's a lot you can do to get yourself on the way to registration and use a consultant to help with the tougher parts. Perhaps you've already done this but if not there's much to learn from others here at the Cove.
Your primary objectives should be to define the processes that you need to create, release and support the software. Ensure everything is controlled, make use of industry standard source control (and use it religiously), formalize and track reviews, from requirements to code inspections to final testing. It's tempting to not record the problems and just fix them instead, but in order to demonstrate the system you need to show how bugs are dealt with.
What development methodology are you using, waterfall, agile, Rational Unified Process?
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