Variscite, a leading global System-on-Module (SoM) designer, developer, and manufacturer, and NRG, a MedTech engineering partner for regulated software systems, have announced a partnership to provide a system level solution for embedded medical products.
Medical device development leaves no room for mistakes. It demands coordinated execution across hardware, embedded software, cybersecurity, validation, and quality management system (QMS) documentation – all toward a single goal: a certified product that remains reliable and available for the long term.
In this new partnership, medical device developers and manufacturers will receive a combination of hardware and software architecture support with targeted MedTech-specific software and engineering services to support precise design and time-to-market requirements.
Variscite says it brings several key advantages to the medical device sector, anchored by its fully in-house, medical-grade ISO 13485-certified manufacturing and direct supply chain control. To safeguard customer investments across product generations, Variscite provides pin-compatible product families that allow developers to scale performance without redesigning the carrier board.
NRG says its strengths include deep system-level expertise with a single, coordinated development interface that covers both architecture and cybersecurity-oriented engineering. By integrating Quality Management System (QMS) documentation right from the start of a project, NRG says it ensures compliance is baked into the development lifecycle.
Additionally, NRG’s simulator-based development methodologies allow hardware and software tasks to run in parallel, flagging potential issues, risks, or incompatibilities earlier in the timeline.
“Our ISO 13485-certified in-house manufacturing, direct R&D engineering support, proven quality, and long-term longevity provide a strong foundation for all companies developing embedded medical products,” said Ofer Austerlitz, VP of Business Development and Sales at Variscite. “Partnering with NRG adds the software system-level MedTech domain expertise and regulatory know-how that turns that foundation into a complete path from concept to successful mass production in all related medical segments.”
“Medical device manufacturers need a development path that reduces uncertainty from the earliest architectural decisions through release readiness,” said Marco Ciambrone, CTO and shareholder at NRG. “After more than 20 years working on regulated MedTech systems, we know that product risk often emerges between disciplines: hardware, firmware, software, usability, cybersecurity, documentation, and validation. By combining Variscite’s proven hardware platforms with NRG’s system-level expertise, we help teams make better technical decisions earlier and move toward product release with greater predictability.”
