topflightapps

On June 25, 2026, UpDoc announced an FDA 510(k) clearance (K253281) it had received on December 23, 2025, for what it calls the first software as a medical device built on patient-facing large language models. The clearance covers insulin and medication management for ...

Four months into a health app build, a hospital procurement checklist lands in your inbox asking for evidence of IEC 62304 conformity. Someone on the team Googles IEC 62304 compliance startup MVP, and the first page serves up design history files, CAPA, and full quality management systems. By next morning’s standup, the working theory is that compliance means a 6-month...

Your attorney just told you you’re a business associate. Or a health system’s security review confirmed it: you handle protected health information, so HIPAA applies to you directly, as a covered entity or business associate. The clock’s running, and year one HIPAA compliance is suddenly your problem. This is the playbook for that first year: the order to do it in, and what e...

Choosing between Convex vs AWS for a HIPAA-compliant healthcare app is a decision framework, not a verdict on which platform is better engineered. The backend you pick is three commitments at once: a compliance posture, a cost structure, and a scalability ceiling.

Get the match wrong and the failure shows up in one of a few shapes. You re-platform under pressure when a...

Before a single claim goes out for one Medicare above-knee prosthesis, the chart already has to carry a physician face-to-face exam with a K-level assessment, a Standard Written Order with diagnosis and functional level, a clinical justification letter, prior authorization from the patient’s DME MAC for the high-cost L-codes, fabrication tracked from prescription to delivery,...