Variscite, NRG Partner to Simplify Embedded Medical Device Development

Variscite and NRG are teaming up 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 of which combine to create a certified, reliable product with long-term availability.

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.

“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, vice president 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.”

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

“Medical device manufacturers need a development path that reduces uncertainty from the earliest architectural decisions through release readiness,” NRG Chief Technology Officer/shareholder Marco Ciambrone stated. “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.”

Variscite offers System-on-Module (SoM) design and manufacturing, and has set the standard for embedded solutions since 2003 with reliable modules. The company offers an extensive arm-based SoM portfolio in the embedded market that features a range of configuration options that span from entry-level to high-performance, powered by robust SoCs such as the NXP i.MX8, i.MX9, and i.MX6 series and the Texas Instruments Sitara AM62. Variscite’s in-house production fully complies with ISO 13485, ISO 9001, and ISO 27001 standards—covering medical-grade manufacturing, quality management, and information security. Coupled with top-tier support and extended product longevity, Variscite delivers products and services throughout the entire product lifecycle, from initial development to end-of-life.

NRG is an Italian technology partner supporting medical device manufacturers and medtech R&D teams in the development, integration, remediation, and evolution of regulated medical products. Founded in 2003, NRG works on complex medical systems where software, firmware, devices, cloud services, clinical workflows, cybersecurity, documentation, and operational continuity must be coordinated as part of a single product architecture. The company supports new product development, hardware/software integration, DICOM and medical imaging workflows, PACS/RIS interoperability, high-reliability cloud and distributed systems, cybersecurity-by-design, technical remediation, validation readiness, and long-term product evolution. NRG’s Quality Management System has been ISO 13485 certified since 2020. The company has supported over 50 R&D projects and 900-plus installations in more than 25 countries.