Israeli System-on-Module (SoM) firm Variscite has partnered with MedTech engineering firm NRG to provide a system-level offering for embedded medical products.

Through a combination of hardware and software architecture support, the two firms will offer medical device developers and manufacturers targeted, MedTech-specific software and engineering services to support precise design and time-to-market requirements.

Medical device development requires coordinated execution across hardware, embedded software, cybersecurity, validation, and quality management system (QMS) documentation — all toward the single goal of a certified product that remains reliable and available for the long term, Variscite said.

Variscite said its medical devices offer:

• 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 said it offers:

• 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, 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.”

NRG CTO and shareholder Marco Ciambrone said the partnership is important because “medical device manufacturers need a development path that reduces uncertainty from the earliest architectural decisions through release readiness.” NRG has worked on regulated MedTech systems for more than 20 years, and brings experience to be able to flag when product risk typically emerges: through 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,” Ciambrone said.

Variscite offers an arm-based SoM portfolio for the embedded market, featuring a wide 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 said its in-house production fully complies with ISO 13485, ISO 9001, and ISO 27001 standards.

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.