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Dear all,
It is great that I found this forum. I am posting for the first time and I am not experienced. My question is very vague because I do not manage to pose it more precisely yet. Maybe you can give me some tips.
We are creating with 3 colleagues a company to commercialize medical software for image-based diagnosis. The main market of our application is the US, and getting 510(k) is our top priority.
We know well how we want the application to be and have the technical knowledge to develop it. However, we have no experience with certification issues. We would have maximum ~10 k$ for certification-related consulting (if absolutely needed, since we have no external funding). But we have our own time and much motivation available.
I have seen the useful replies to KAMay at thread 39302 (cannot include link here because it is my first post) but without experience I find it difficult to know where to start.
I see many options but maybe none of them is correct or we have to do all in parallel:
*read the FDA's Principles of Software validation several times until understanding how to establish a development process which fits with it
*buy IEC 62304 and study it
*buy and look into ISO 9001, ISO 13485, ISO 14971, IEC/TR 80002-1
*get a consultant since the first day and ask him for help and templates (then our budget might be gone since the beginning)
Based on your experience, what should we do and in which order?
I guess that most people here work in a company with a complete infrastructure and a large budget only for this purpose, so my questions might sound very naive. Still, I would be grateful for any tips. If you think that we have no chance of getting 510(k) without investing much more money (besides our own time), this would be also an important piece of information.
Thanks! meddi
It is great that I found this forum. I am posting for the first time and I am not experienced. My question is very vague because I do not manage to pose it more precisely yet. Maybe you can give me some tips.
We are creating with 3 colleagues a company to commercialize medical software for image-based diagnosis. The main market of our application is the US, and getting 510(k) is our top priority.
We know well how we want the application to be and have the technical knowledge to develop it. However, we have no experience with certification issues. We would have maximum ~10 k$ for certification-related consulting (if absolutely needed, since we have no external funding). But we have our own time and much motivation available.
I have seen the useful replies to KAMay at thread 39302 (cannot include link here because it is my first post) but without experience I find it difficult to know where to start.
I see many options but maybe none of them is correct or we have to do all in parallel:
*read the FDA's Principles of Software validation several times until understanding how to establish a development process which fits with it
*buy IEC 62304 and study it
*buy and look into ISO 9001, ISO 13485, ISO 14971, IEC/TR 80002-1
*get a consultant since the first day and ask him for help and templates (then our budget might be gone since the beginning)
Based on your experience, what should we do and in which order?
I guess that most people here work in a company with a complete infrastructure and a large budget only for this purpose, so my questions might sound very naive. Still, I would be grateful for any tips. If you think that we have no chance of getting 510(k) without investing much more money (besides our own time), this would be also an important piece of information.

Thanks! meddi



you are right, I start going crazy just by seeing the amount of documents which need to be read. It is insane! Maybe in a few months I ask you at which shop you bought the hat to get the same one...