FDA Submission Consultancy - Registering and marketing our products in the US

M

mike65

#1
We are a ISO13485 certified European medical device firm producing and marketing portable electromechanical devices. Our products are CE marked. We would like to investigate the feasibility of registering and marketing our products in the US and to estimate the cost and effort that will be required for the registration. Our main concern is the embedded software that has been developed over last 15 years and may require reengineering to match the FDA requirements.

Does anyone have experience on FDA approval projects for devices (classII and above) of which the software has started to be developed when the current software development standards (e.g. IEC 62304) did not exist? What are the options available? Do we need to develop everything from scratch? Our products are operating on the field with no issues for years..

It is difficult to estimate how much refactoring will be required to meet the FDA requirements and I would really appreciate if any professional with experience on this area could provide us consultancy servrices on this.
 
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P

PaulGr

#2
Re: FDA submission consultancy

Welcome to the cove!

You will need to convince the FDA that your software controls were sufficient. Just the fact you had no issues won't be sufficient. The total amount of work depends of course on what you have - even if you did not apply 62304, you will have some form of requirements / architecture / testing /...
Furthermore, your level of concern (see FDA software guidance for definitions) and product class will influence what you'll have to do.

Since your product are now CE marked, you probably have some processes related to post market risk management and software maintenance.

You might want to tell us in which country / state you are so interested consultants can contact you.

Good luck!
 
M

mike65

#3
Thanks! There are procedures and documentation in place, but since our company does not have experience on FDA registration we cannot estimate the depth of refactoring that will be required. I understand that this cannot be answered without a good knowledge of what exists already and the specifics of our product. Consultants able to help by offering their services are welcomed to send private message.
 
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