Variscite and NRG Partner to Reduce Medical Device Development Risk

Variscite, a leading global System-on-Module (SoM) designer, developer, and manufacturer, and NRG, a medtech engineering partner for regulated software systems, 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’s advantages for medical devices include:

• Fully in-house, medical-grade ISO 13485-certified manufacturing

• Extensively field-validated SoMs with proven deployments across medical and industrial applications worldwide

• Configurable modules that can be optimized to specific feature-set and target price

• Pin-compatible product families that allow performance scaling without carrier board redesign to protect customer investment across product generations

• Product longevity of up to 15 years

• Stable lead time backed by direct supply chain control and in-house production facilities

• Free, direct technical support from Variscite engineers

NRG’s strengths include:

• Single coordinated development interface, covering architecture and cybersecurity-oriented engineering

• Integration of QMS documentation from the project’s onset

• Simulator-based development methods that parallelize hardware and software activities and identify potential issues, risks, or incompatibilities earlier in the timeline

• Agile workflows and execution frameworks adapted to medtech traceability and release-readiness requirements

"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.”

For more information, visit https://variscite.com/ or https://www.nrgsys.it/en.