CLASS IIA Diagnostic Software
22 Aprile 2026
Case History by NRG, our Partner in MedTech and Digital Health
Intraoperative Software
Goal-based project plus maintenance
PROJECT
Customer
Italian company specialized in intraoperative radiotherapy (IORT), delivering laser-based solutions that enable precise, targeted radiotherapy directly in the operating room.
Request
The customer was looking for a partner to modernize an end-to-end radiotherapy solution—from treatment planning to delivery—previously running on obsolete hardware control panels. With the original hardware/firmware development team no longer available, we were engaged to lead a full re-engineering effort. We designed and validated prototypes for new electronic boards and firmware, and built a next-generation control software platform with an intuitive user experience—without compromising on the underlying complexity. Throughout the project, we kept regulatory requirements front and center, supporting compliance for a high-risk medical device.
Type of collaboration
Goal-based project + maintenance
HOW WE DELIVERED
REVAMPING AND NEW FEATURES
We reimagined and rebuilt a legacy system affected by usability and stability limitations, delivering a more reliable product and introducing new capabilities to boost performance.
UNBLOCKING IT DECISIONS
Following a major shift in the R&D organization, the customer needed an experienced partner to restore momentum—rebuilding critical technical know-how and accelerating decision-making across the new system design.
OVERCOMING SPECIFIC TECHNICAL OBSTACLES
We integrated a DICOM worklist module into the new platform and supported alignment with the regulatory expectations for high-risk devices—reducing integration risk and smoothing the path to compliance.
WORKING DESIGN AND DOCUMENTATION OF THE RIGHT REDUNDANCIES
For Class IIIc medical devices, auditors expect robust, well-justified redundancies—designed in a way that strengthens safety without driving unnecessary cost and complexity. By running joint design work alongside regulatory documentation in parallel, we met these expectations with minimal rework and kept the program on track.
Every phase was thoroughly documented to streamline certification and support a smooth, audit-ready submission.
