Document & text analysis for clinical research
16 Gennaio 2023
CLASS IIIC Intraoperative Software
24 Aprile 2026
Case History by NRG, our Partner in MedTech and Digital Health
Diagnostic Software
Agile delivery contract as an extension of the internal IT Team
PROJECT
Customer
Italian high-tech company designing and manufacturing advanced solutions for audiology and vestibology, supporting clinicians with cutting-edge diagnostic equipment.
Request
The customer needed a delivery partner to extend its proprietary software platform, enabling seamless control of a new generation of diagnostic medical devices headed to market.
While the company had a sizeable development team, internal capacity was fully absorbed by continuous improvements to an established product line.
Because the new device fell under a different regulatory class, the program required substantial updates to the customer’s development approach and documentation practices.
Type of collaboration
Agile delivery contract as an extension of the internal IT team
HOW WE DELIVERED
REVAMPING AND NEW FEATURES
We delivered a new application module focused on auditory evoked potentials, enabling clinicians to assess diagnostic signals through a streamlined workflow.
UNBLOCKING IT DECISIONS
After an unsatisfactory experience with the previous supplier, the customer brought in NRG to operate as an extension of its IT department—turning detailed specifications into a production-ready application.
OVERCOMING SPECIFIC TECHNICAL OBSTACLES
We integrated a DICOM worklist module into the new system and aligned delivery with the quality expectations for high-risk devices—supporting safer integration and smoother releases.
WORKING WITHIN AN EXISTING QUALITY SYSTEM
The customer operates a mature, highly structured quality management system that underpins the development of dozens of products.
Because development and maintenance processes were tightly interconnected, it was essential that our documentation fit seamlessly into existing workflows.
We tailored our documentation outputs so they could be easily adopted and maintained by the customer’s regulatory team—without adding operational overhead.
We delivered regulatory documentation directly within the customer’s quality system—acting as a true extension of the internal IT team and enabling faster, compliant product delivery.
