Hello everyone,
I am currently dealing with a situation where a product that was not a medical device before might have to be transitioned to the MDR space. We already dealth with most of the requirements (13485, 14971...) but with regards to 62304 it becomes tricky since the product is standalone software.
62304 foresees that old software can be used as legacy software, in case it was placed on the market before 2010. This is the case for the initial version, but it was not placed on the market as a medical device and was updated thereafter regularly. Therefore i guess the clause about legacy software is not applicable.
There is a lot of documentation available on the development including verification&validation, change requests etc., but it is not 62304 compliant. Would we have to re-do everything from scratch (reverse-engineering?) or is there any chance to "transform" old documentation and development to be in compliance with 62304? Treat it as SOUP etc.?
Thanks!
I am currently dealing with a situation where a product that was not a medical device before might have to be transitioned to the MDR space. We already dealth with most of the requirements (13485, 14971...) but with regards to 62304 it becomes tricky since the product is standalone software.
62304 foresees that old software can be used as legacy software, in case it was placed on the market before 2010. This is the case for the initial version, but it was not placed on the market as a medical device and was updated thereafter regularly. Therefore i guess the clause about legacy software is not applicable.
There is a lot of documentation available on the development including verification&validation, change requests etc., but it is not 62304 compliant. Would we have to re-do everything from scratch (reverse-engineering?) or is there any chance to "transform" old documentation and development to be in compliance with 62304? Treat it as SOUP etc.?
Thanks!