Variscite, a developer and manufacturer of System-on-Modules (SoMs), has partnered with medtech engineering company NRG to provide an integrated hardware and software development solution for embedded medical devices, as manufacturers face increasing regulatory and product development requirements.
The collaboration aims to help medical device developers reduce development risks by combining embedded hardware platforms with software engineering, cybersecurity, validation and quality management expertise.
Medical device development requires coordinated execution across hardware, embedded software, regulatory compliance and quality management systems to achieve certification while ensuring long-term product reliability. The two companies said their partnership is designed to address these challenges through a unified development approach that supports faster and more predictable product development.
Under the agreement, customers will receive hardware architecture support from Variscite alongside NRG’s medtech-focused software engineering services. The combined offering is intended to help manufacturers meet design, compliance and time-to-market objectives while reducing integration complexity.
Variscite said its portfolio provides several features tailored to medical applications, including ISO 13485-certified in-house manufacturing, configurable System-on-Modules, long-term product availability of up to 15 years and pin-compatible product families that allow performance upgrades without redesigning carrier boards.
The company also highlighted its direct supply chain control, stable lead times and in-house engineering support as advantages for manufacturers developing long-life medical products.
NRG brings expertise in regulated software systems and medical device engineering. Its services include system architecture design, cybersecurity engineering, quality management system (QMS) documentation, validation support and simulator-based development methods that enable hardware and software development to proceed in parallel.
According to the companies, the approach allows development teams to identify design issues and compatibility risks earlier in the product lifecycle, reducing the likelihood of delays during validation and certification.
Ofer Austerlitz, Vice President of Business Development and Sales at Variscite, said the company’s certified manufacturing capabilities and long-term product support provide a strong foundation for embedded medical devices. He added that NRG’s regulatory and software expertise complements Variscite’s hardware platform by helping customers move from product concept to commercial manufacturing.
Marco Ciambrone, Chief Technology Officer and shareholder at NRG, said uncertainty in medical device development often arises where hardware, firmware, software, cybersecurity and regulatory documentation intersect.
He said combining Variscite’s embedded computing platforms with NRG’s system-level engineering capabilities enables development teams to make technical decisions earlier in the process while improving readiness for regulatory approval.
