Variscite and NRG Team Up to Simplify Embedded Medical Device Development

Getting a regulated medical product to market requires more than great hardware. Engineering teams must simultaneously manage embedded software, cybersecurity, QMS documentation, and validation – keeping all of it aligned around a single certified, long-term-reliable product. That is precisely the challenge a new Variscite and NRG partnership is designed to address.

Variscite, a leading System on Module manufacturer with proven expertise in medical applications, has joined forces with NRG, an engineering firm specializing in regulated medtech systems, to deliver an integrated hardware-software solution for companies building embedded medical products. The partnership gives development teams access to both a proven hardware platform and the software and engineering capabilities needed to support regulated development goals and product readiness.

Variscite – A Hardware Foundation Built for Regulated Environments

Variscite’s contribution to the partnership rests on a manufacturing and product infrastructure purpose-built for regulated industries:

• ISO 13485-certified manufacturing, handled entirely in-house
• SoMs with extensive field validation across both medical and industrial deployments globally
• Modules configurable to a specific feature set and cost target
• Three pin-compatible SoM families enabling performance upgrades without requiring a carrier board redesign, safeguarding investment across generations
• 15 years of product availability
• Predictable lead times through direct supply chain ownership and in-house production
• Engineering support at no additional cost, provided directly by Variscite’s engineering team.

“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.”

NRG – Closing the Gap Between Engineering and Regulatory Compliance

NRG contributes the systems-level software and regulatory depth that takes a strong hardware foundation all the way to certification:

• A unified point of contact for architecture decisions and cybersecurity-focused engineering
• QMS documentation woven into the project from day one, not added after the fact
• Simulation-driven workflows that allow hardware and software workstreams to run in parallel, surfacing risks and incompatibilities well before they become costly
• Delivery frameworks that balance agile execution with the traceability and release standards medtech demands

“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.”

Start Your Medical Device Program on Solid Ground

Building an embedded medical product? Learn how Variscite’s ISO 13485-certified SoMs and NRG’s medtech engineering services can support your program –  contact us.