Variscite and engineering consultancy NRG have formed a partnership aimed at helping medical device manufacturers accelerate product development while navigating increasingly complex regulatory and cybersecurity requirements.
The collaboration brings together Variscite’s Arm-based embedded computing platforms with NRG’s expertise in software engineering for regulated industries, creating a combined development offering that spans hardware, embedded software, system architecture and compliance.
The companies said the partnership is intended to support medical device manufacturers throughout the product lifecycle, from initial design and development to validation, certification and production.
Integrated Engineering for Regulated Medical Devices
Developing connected medical devices has become more complex as manufacturers face stricter regulatory standards alongside growing expectations for cybersecurity and long-term product support.
Rather than sourcing hardware and software expertise separately, the partnership provides customers with coordinated engineering resources across multiple disciplines, including embedded hardware, software architecture, validation and quality management.
Variscite specializes in Arm-based System-on-Modules (SoMs) used in embedded computing platforms, while NRG focuses on engineering software-intensive products for highly regulated industries, including healthcare, defense, industrial automation and the Internet of Things.
Focus on Compliance and Long-Term Support
According to the companies, the combined offering is designed to address many of the technical and regulatory challenges common to modern medical device development.
These include:
- Safety lifecycle documentation
- Software validation
- Cybersecurity architecture
- Regulatory compliance
- Long-term product maintenance
Variscite also brings ISO 13485-certified manufacturing, configurable embedded modules and long-term product availability of up to 15 years. Its System-on-Modules allow customers to upgrade processors without redesigning carrier boards, helping extend product lifecycles while reducing engineering effort.
Software Engineering Complements Embedded Hardware
NRG will contribute engineering services focused on software architecture, cybersecurity, quality management systems and development methodologies tailored to regulated medical environments.
The company also supports simulator-based software development and documentation processes intended to simplify regulatory approval and reduce development risk.
“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.”
Medical Device Development Continues to Grow More Complex
Medical device manufacturers are increasingly expected to deliver connected products that meet evolving cybersecurity standards while complying with strict regulatory frameworks and accelerating time to market.
As embedded software becomes a larger component of healthcare technology, coordination between hardware, firmware and software engineering teams is becoming increasingly important throughout the development process.
NRG Chief Technology Officer Marco Ciambrone said many of today’s engineering challenges occur where hardware, embedded software, cybersecurity, documentation and validation requirements intersect, making integrated development approaches increasingly valuable.
The Bottom Line
Medical devices are becoming more software-defined, connected and subject to stricter cybersecurity and regulatory requirements. Partnerships that combine embedded hardware platforms with specialized software engineering services can help manufacturers reduce development complexity, streamline certification efforts and shorten time to market. As healthcare technology continues evolving, integrated engineering approaches are becoming increasingly important for organizations developing next-generation medical devices.