The companies will collaborate on a system-level solution for embedded medical devices.
Variscite, a global provider of System-on-Module (SoM) solutions, and NRG, a medtech engineering specialist for regulated software systems, have partnered to deliver comprehensive system-level solutions for embedded medical devices.
The collaboration is designed to help medical device manufacturers streamline development by combining advanced hardware and software expertise. Together, the companies will provide support across hardware design, embedded software, cybersecurity, validation, and Quality Management System (QMS) documentation.
By integrating their capabilities, Variscite and NRG aim to help developers accelerate product development, meet regulatory requirements, and bring reliable, long-term medical device solutions to market more efficiently.
Key benefits of Variscite’s solutions for medical devices include:
- ISO 13485-certified, medical-grade manufacturing performed entirely in-house.
- Highly reliable System-on-Modules (SoMs) validated through extensive deployments in medical and industrial applications worldwide.
- Flexible module configurations that can be tailored to specific features and budget requirements.
- Pin-compatible product families that enable seamless performance upgrades without redesigning carrier boards, protecting long-term investments.
- Long-term product availability with lifecycle support of up to 15 years.
- Consistent lead times supported by direct supply chain management and in-house manufacturing capabilities.
- Complimentary technical assistance provided directly by Variscite’s engineering team.
Key strengths of NRG include:
- A unified development approach with a single point of coordination for system architecture and cybersecurity-focused engineering.
- Early integration of Quality Management System (QMS) documentation to support regulatory compliance from the start.
- Simulator-driven development processes that enable parallel hardware and software development while identifying risks and compatibility issues earlier.
- Agile development methodologies tailored to the traceability, compliance, and release-readiness requirements of the medical technology sector.
“Our ISO 13485-certified in-house manufacturing, dedicated R&D engineering support, proven product quality, and long-term availability provide a reliable foundation for medical device developers,” said Ofer Austerlitz, VP of Business Development and Sales at Variscite. “By partnering with NRG, we are extending that foundation with specialized medtech software expertise and regulatory knowledge, creating a comprehensive development pathway that helps bring medical products from concept to large-scale production across a wide range of healthcare applications.”
“Medical device manufacturers require a development approach that minimizes risk and uncertainty from initial design decisions through final product release,” said Marco Ciambrone, CTO and shareholder at NRG. “With more than two decades of experience in regulated medical technology systems, we understand that challenges often arise at the intersection of hardware, firmware, software, usability, cybersecurity, documentation, and validation. By combining Variscite’s proven hardware solutions with NRG’s system-level engineering expertise, we enable development teams to make informed decisions earlier, reduce risks, and achieve a more predictable path to market.”
