One post tagged with "regulated-environment"

MedTech software development operates under a level of regulatory scrutiny that most industries never experience. FDA 21 CFR Part 11, IEC 62304, HIPAA, MDR in Europe — these aren't guidelines you can selectively follow. They're legally binding requirements where non-compliance can result in product recalls, criminal liability, and patients being harmed. The FDA's Software Validation Guidelines emphasize that software used in medical devices must be developed under documented, repeatable processes with full traceability.

For MedTech CTOs, the challenge is building software that saves lives while satisfying regulators that your process is rigorous enough to trust. Engineering metrics make this possible without turning your development process into a bureaucratic standstill.