Insights
Practical, no-fluff guides on building medical device software — regulatory lifecycle, verification & validation, device connectivity, and medical-grade private AI.
IEC 62304 Software Development Lifecycle: A Practical Guide
What IEC 62304 actually requires for medical device software — safety classification (A/B/C), lifecycle activities, documentation, and how it connects to ISO 14971 risk management and FDA submissions.
Read articleVerification & Validation for Medical Device Software
What V&V means for FDA-regulated software, the difference between verification and validation, what an FDA submission expects, and how traceability, test protocols, and the Design History File fit together.
Read articleBLE Connectivity for Medical Devices: A Field Guide
Why Bluetooth Low Energy dominates connected medical devices, the real engineering challenges (pairing, bonding, reliability, power, OS quirks), and the security and FDA considerations for wireless device software.
Read articleMedical-Grade Private AI: Open Models on Compliant Infrastructure
How to add AI to medical and healthcare software without sending PHI to a public model — private and dedicated hosting, no-training guarantees, SOC 2-attested infrastructure, and validation under IEC 62304, ISO 14971, GMLP, and FDA PCCP guidance.
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