- About us
- Company details
NRG is an engineering partner specialized in the design and development of regulated MedTech software.
Since 2003, we have been supporting companies and startups in the development of complex and mission-critical software systems.
Our Quality Management System has been ISO 13485 certified since 2020, enabling us to design software for medical devices from early concept to CE and FDA readiness.
We develop custom software solutions for medical devices and regulated systems, operating in highly controlled environments where quality, safety and risk management are integral to the project.
Our expertise covers the full development lifecycle: requirements analysis, software architecture, development, verification, validation, system integration and regulatory support.
We combine competencies in software engineering, embedded systems, system integration, UX for clinical and mission-critical environments, cybersecurity and regulatory compliance, working closely with our clients’ teams to ensure technical coherence, traceability and measurable results.
NRG operates as a long-term technical partner, transforming engineering complexity into reliable, scalable and certifiable MedTech solutions.
Year of establishment:
2003
Number of employees:
FROM 10 TO 19 EMPLOYEES
Annual turnover:
between 0.5 and 2.5 million Euro
Reference year of turnover:
2023
Export turnover:
Less than 75.000 Euro
Activities:
Computer programming activities
Computer consultancy and computer facilities management activities
Other information technology and computer service activities
Other specialised design activities
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NRG is a regulated MedTech software engineering partner supporting companies and startups in the development of complex, mission-critical systems. Since 2003, we have been designing and developing custom software for regulated environments, combining engineering rigor, domain expertise and a structured, compliant-by-design approach. Our quality management system has been ISO 13485 certified since 2020. We support medical device software development from concept to CE/FDA readiness, covering architecture, development, verification, validation and system integration. We work as a long-term technical partner, transforming engineering complexity into reliable, scalable and certifiable MedTech solutions. 100% custom projects. Designed and developed in Italy.
NRG – Regulated MedTech Software Engineering Capabilities
- Contact Information
- Business Proposals
Company:
NRG SYS S.P.A.
Web site:
Address:
VIALE ALCIDE DE GASPERI 24
City:
L'AQUILA (AQ)
Zip Code:
67100
E-commerce:
Social media:
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Regulated MedTech Software Development
Custom software development for medical devices and regulated systems, designed to be compliant with ISO 13485, MDR and FDA requirements.
We support the full lifecycle from concept to certification readiness, ensuring reliability, traceability and long-term maintainability.
Web site
https://www.nrgsys.it/
System Integration & CE/FDA Certification Support
End-to-end system integration combining software, embedded systems and hardware into validation-ready architectures.
We support CE and FDA certification processes through structured documentation, verification, validation and regulatory alignment.
Web site
https://www.nrgsys.it/
Rapid Prototyping, MVP & R&D Projects
Rapid prototyping and MVP development for innovative MedTech projects and R&D initiatives.
We help companies move from early concepts to functional prototypes and technology readiness levels (TRL), reducing technical and regulatory risks.
Web site
https://www.nrgsys.it/
UX Design for Clinical & Mission-Critical Systems
User experience design for clinical, industrial and mission-critical environments.
We design safe, usable and compliant interfaces, reducing human error and supporting regulatory and usability requirements.
Web site
https://www.nrgsys.it/
Legacy Software Revamping & Project Rescue
Modernization and recovery of legacy or critical software projects.
We address technical debt, security issues and compliance gaps, restoring system stability and preparing products for certification and future scalability.
Web site
https://www.nrgsys.it/