regulated development

What technical due diligence actually asks about your medical device software

Diligence rarely fails on the device. The device works. The bench data is good. The clinical story holds up. Then a request list arrives, and somewhere between item fourteen and item twenty-two there are five or six lines about software documentation — and that is

agile

Three Failure Patterns in Agile FDA Software Development

Most teams building Software as a Medical Device (SaMD), digital therapeutics, or device-connected software run sprints. Most of them are also making one of three mistakes that break their IEC 62304 compliance — and they don't usually find out until submission prep. Check out our

regulated development

IEC 62304 Clause 5 in practice: building a development process that survives FDA review

Clause 6 of IEC 62304 is where most teams get hurt. We covered that last month — the maintenance traps, the frozen risk files, the patch backlogs that become audit findings.