Variscite, NRG partner to reduce medical device development risk

Variscite, an Israel-based System-on-Module (SoM) designer, developer and manufacturer, and NRG, an Italian medtech engineering partner for regulated software systems, have announced a partnership to provide a system level solution for embedded medical products, according to a media release.

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, the media release said.

“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.”

“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,” said Marco Ciambrone, CTO and shareholder at NRG. “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.”