TEL AVIV, Israel--(BUSINESS WIRE)--Variscite, a leading global System-on-Module (SoM) designer, developer, and manufacturer, and NRG, a medtech engineering partner for regulated software systems, today 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.”
About Variscite
Variscite is a global leader in System on Module (SoM) design and manufacturing, setting the standard for embedded solutions since 2003 with high-quality, reliable modules. The company offers the most extensive Arm-based SoM portfolio in 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's in-house production fully complies with ISO 13485, ISO 9001, and ISO 27001 standards - covering medical-grade manufacturing, quality management, and information security - ensuring the highest quality. Coupled with top-tier support and extended product longevity, Variscite consistently delivers dependable products and services throughout the entire product lifecycle, from initial development to end-of-life. For more information, please contact Variscite’s sales team at sales@variscite.com or https:/variscite.com/contact-us.
About NRG
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 more than 50 R&D projects and 900+ installations across more than 25 countries. To learn more, visit https://www.nrgsys.it/en.
Contacts
JPR Communications
Joe Austin
joea@jprcom.com
