S
Hi,
when submitting a special 510k ffor new Operating Systems for data management software (stand alone used to retrieve data from Class II medical devices), is it required to include the following:
SW Architecture Document
SW Design Document
SW Development and Project Management Plan
Please provide Scenarios based on some assumption, if you believe you still need information to answer this question.
Thanks,
Silvertabb
when submitting a special 510k ffor new Operating Systems for data management software (stand alone used to retrieve data from Class II medical devices), is it required to include the following:
SW Architecture Document
SW Design Document
SW Development and Project Management Plan
Please provide Scenarios based on some assumption, if you believe you still need information to answer this question.
Thanks,
Silvertabb