
KSASoftware is very familiar with many of the standards, protocols, formats, and processes used in developing software for the medical and scientific technology industries.
Medical Protocols/Standards
FDA 510K Submission | |
HIPPA Compliance | |
21 CFR Part 11 | |
CCHIT | |
HL7 |
Industry Formats
DICOM/ACR-NEMA | |
ASTM | |
MXF | |
AAF | |
VML |
Design Process
Formal Design Control Policy | |
SDLC | |
UML |
FDA 510K Submission