Turn-Key Life-Critical Software Engineering: FDA-Compliant Data Provisioning System for Galil Medical

We engineered, developed, and deployed a turn-key, multi-disciplinary production data provisioning and firmware validation framework for Galil Medical, operating under zero-fault and strict life-safety constraints.

The core software acts as the trusted source of truth inside the manufacturing assembly. It orchestrates real-time communication between Windows platforms and specialized hardware stations to permanently inject encrypted serialization, tracking data, and unique packaging profiles onto integrated memory chips embedded within every individual medical needle. By applying the SHA-1 authentication algorithm onto Maxim integrated circuits, our software seals the immutable data required for safety validation. When deployed in clinical environments, this encrypted payload is read by external medical operating consoles, empowering them to systematically block activation if the needle's verified sterilization lifespan has expired.

At the client's request, the backend architecture was built upon a proprietary, high-efficiency NoSQL database, engineered to handle advanced, rapid search pattern indexing without losing deterministic latency.

Proving the exceptional stability and evolutionary readiness of our codebase, the system has operated continuously for years with zero reported runtime defects. We were later retained to upgrade the system, seamlessly integrating additional external data-sampling hardware interfaces without impacting core stability or generating regression errors.

Both the initial lifecycle and the subsequent hardware upgrade were verified and documented in strict compliance with FDA medical device regulations, including tamper-proof **Audit Trail logging** and life-critical software verification guidelines.

Customer Validation & Recommendation Letter (Written in Hebrew):