FDA requirements mostly target the SDLC: risk analysis, change control, documentation, v&v, &c. Companies are afforded a surprising amount of flexibility in implementation. Basically, you must have a documented process that you follow, but you're left to your own devices in creating the process. Deviations from voluntary industry standards (e.g., TIR 45) is permissible since they're not specifically required. The DoD, aerospace, and automotive industries have in comparison far more detailed and strict regulatory requirements.
