R
regmeddevices
We have a Class II software device (regulation 21 CFR 892.2050) and intended to be used by dentists.
Our Software development life cycle (SDLC) is similar to waterfall and IEC 62304 but not in 100% compliance with IEC 62304 and we cannot submit a declaration of conformance with IEC 62304. Should we demonstrate in our document at several places that our SDLC is similar to waterfall and follows IEC 62304.
Thanks
Our Software development life cycle (SDLC) is similar to waterfall and IEC 62304 but not in 100% compliance with IEC 62304 and we cannot submit a declaration of conformance with IEC 62304. Should we demonstrate in our document at several places that our SDLC is similar to waterfall and follows IEC 62304.
Thanks