Y
yurucamp
Hi ! I'm fairly new to the site and the world of standards in general, and I find myself with a lot of questions everyday.
Currently, the company I work for almost finished developing an embedded software, run by a platform also developed by the company. But it was only recently that it was established as a medical software.
In order to put our product on the market, we need to comply to the MDD directive and decided to apply the hamonized standards in order to. The thing is, the standard EN/IEC 62304 has a huge part about the development process of the software, and our software is almost complete. At the end of the day, if we establish every process and documents needed, can we say we comply to this standard?
The implementation of some certain software items haven't been tested (no test procedure) and for those that did go through tests, we haven't documented it.
So I was wondering if stating we're complying to 62304 was a "lie" since it wasn't taken into account since the beginning, or if regulatory authorities could invalid our CE marking because of it.
Sorry if some of my statements seem naive, as I said, I'm new to the field.
I might post more on this thread if any more questions pop up.
Thanks for helping ! Please feel free to ask for any complementary information if it helps answering my question.
Currently, the company I work for almost finished developing an embedded software, run by a platform also developed by the company. But it was only recently that it was established as a medical software.
In order to put our product on the market, we need to comply to the MDD directive and decided to apply the hamonized standards in order to. The thing is, the standard EN/IEC 62304 has a huge part about the development process of the software, and our software is almost complete. At the end of the day, if we establish every process and documents needed, can we say we comply to this standard?
The implementation of some certain software items haven't been tested (no test procedure) and for those that did go through tests, we haven't documented it.
So I was wondering if stating we're complying to 62304 was a "lie" since it wasn't taken into account since the beginning, or if regulatory authorities could invalid our CE marking because of it.
Sorry if some of my statements seem naive, as I said, I'm new to the field.
I might post more on this thread if any more questions pop up.
Thanks for helping ! Please feel free to ask for any complementary information if it helps answering my question.