NRG
Regulated MedTech Software Engineering Partner
ISO 13485 certified · From concept to CE/FDA readiness
About Us - MedTech Software Engineering Partner for Regulated Systems
We build original software for industries where quality is not an option.
Every project is unique, just like yours .
NRG is an Italian engineering partner for regulated MedTech software and systems.
Since 2003 we have supported companies and startups in complex regulated environments, where quality, safety and risk management are core requirements.
Our quality system has been ISO 13485 certified since 2020. By integrating expertise in software, embedded systems, firmware, regulatory compliance and cybersecurity, we deliver scalable, verifiable and compliant solutions.
We work closely with our clients’ teams to ensure structured methods, technical coherence and measurable results from concept to CE/FDA readiness.
How we work - Method for Regulated MedTech Software Development
Method. Precision. Results.
Engineering that turns complexity into reliability
Every project follows a structured process designed to reduce risk, timelines and complexity.
From concept to certification, we ensure technical control and continuity.
A methodology validated through years of MedTech experience.
Every project is traceable, verifiable and ready for certification.
Regulated
by design
We design projects with regulatory requirements, certification paths and risk management built in from the very beginning (ISO 13485, CE, FDA).
Custom development and
end-to-end device engineering
We deliver tailor-made solutions by integrating software, embedded systems, hardware and firmware into reliable and scalable architectures.
R&D-driven approach and
continuous collaboration
We work in close collaboration with our clients’ teams, supporting research, prototyping and validation activities.
NRG - Complex problems. Concrete solutions.
ISO 13485
certified
We apply the most rigorous standards from the very early stages of development. Our compliant-by-design methodology ensures quality, safety and full traceability for every medical device.
One team,
one integrated vision
From hardware and firmware development to software and UX: a coordinated, aligned ecosystem designed to reduce complexity and validation timelines.
No surprises,
just results
Transparent processes, rigorous methodology and continuous control ensure reliability and predictability at every stage of development.
Services - Regulated MedTech Software Engineering Services
From software design to certification.
We integrate engineering expertise to reduce risk, timelines and complexity.
We design and develop custom software for medical devices and regulated systems, ensuring compliance with ISO 13485, MDR and FDA requirements.
We support the project at every stage: concept, functional analysis, design, development, verification, validation, release and maintenance.
An ISO 13485–certified team operating according to rigorous engineering quality and precision standards.
01.
Custom Software for Regulated MedTech Systems
We design and develop full-custom software for medical devices and regulated systems.
02.
System Integration
& Certification
Support
Integrated hardware, firmware and software systems ready for CE/FDA certification.
03.
Secure & Scalable infrastructures
Cloud and hybrid architectures for mission-critical and regulated environments.
04.
UX for Clinical &
Mission-Critical
Environments
Usability-validated interfaces that reduce human error in clinical contexts.
05.
Revamping
& Modernization
Modernization of regulated software while preserving compliance and traceability.
06.
Embedded Software,
Hardware & Firmware
Embedded systems development for medical devices and integrated platforms.
07.
Software Project
Rescue
Recovery of stalled or high-risk MedTech software projects.
If it’s complex,
it’s ours.
Every project is a unique technological challenge:
if it’s complex, chances are we’re already working on it,
and if it doesn’t exist yet, we design it together with you.
Why clients choose us
Complex solutions, made simple.
For real.
Every project we take on is unique.
That’s why we work as partners, not as simple vendors: we bring method, experience and strategic vision.
We don’t develop generic code and we don’t sell off-the-shelf solutions. We design and build software with a clear goal: turning technical and regulatory complexity into concrete, measurable value.
Since 2003, we have been supporting MedTech companies and startups in the development of safe, compliant and market-ready products, reducing risk and uncertainty throughout the entire journey.
Real
expertise
We apply documented and traceable Agile approaches, in full compliance with ISO 13485, MDR, FDA and GDPR.
Surgical
precision
We write code where there is no margin for error. Reliability is a design condition, not a goal.
Method and
transparency
We work with clear, shared and traceable processes to ensure control and predictability at every stage.
Security and
data protection
The data handled by the systems we develop is managed according to cybersecurity and privacy-by-design best practices, in compliance with HIPAA and European regulations.
Affidabilità e
riservatezza
We honor every commitment and protect our clients’ intellectual property as if it were our own.
All projects are covered by NDAs.
Agile mindset and
measurable results
Responsive, focused and always value-driven: we reduce complexity through concrete, verifiable solutions.
NRG in numers
20+
Year of experience
50+
R&D Projects
900+
Installations over 25 Countries
100%
Audit success rate
End-to-End Capabilities
An integrated ecosystem for MedTech development
Engineering, regulation and collaboration to reduce complexity and risk.
We are building an ecosystem of complementary expertise to support increasingly complex MedTech projects.
Together with our partners, we are consolidating a strategic direction focused on delivering a unified, certifiable and traceable technical flow, designed to turn complexity into scalable solutions compliant with ISO 13485, CE (MDR/IVDR) and FDA standards.
A single technical point of contact
We coordinate software, hardware, firmware and regulatory expertise to simplify project management and reduce risk points.
Certified partner network
We collaborate with selected and certified partners to cover the entire MedTech technology stack, while maintaining consistency and quality across the whole value chain.
Compliance without compromise
Regulatory compliance is not an afterthought, but an integral design element from the earliest stages of development.
Shared innovation
We work in synergy with clients and partners to develop sustainable, robust and market-ready solutions.
Real cases. Tangible results.
Every project is a story of precision, compliance and shared innovation.
Challenge
Integrated system project (wearable, embedded and server-side) originally developed as an undocumented prototype, with identified security vulnerabilities.
NRGsys intervention
Complete re-harmonization of the software and hardware stack, architectural redesign, creation of verification test suites and formalization of system requirements documentation.
Result
Transformation of the prototype into a scalable, secure and validation-ready product.
Value
An architectural structure aligned with cybersecurity best practices and ready for subsequent certification processes.
Challenge
To improve a Class IIIC intraoperative medical software system, ensuring development continuity, security and compliance with European regulations.
NRGsys intervention
Complete re-engineering with an RBAC-based architecture, optimized UX, and multi-layer documentation validation across software, firmware and electronics.
Result
Successful audit completion with no findings, increased system reliability, and roadmap maintained even after critical reviews.
Value
Development processes aligned with CE/FDA best practices, providing a solid foundation for future certified versions.
Challenge
To develop an AI-based augmented reality system for multimodal analysis (CT/MRI), designed to meet CE and FDA regulatory requirements.
NRGsys intervention
We designed the complete system architecture, optimized the image processing pipeline, and managed regulatory validation in close coordination with the clinical team.
Result
A stable and integrated platform, ready for clinical validation and MDR/FDA regulatory requirements.
Value
MDR/FDA pathway completed with no findings. Effective convergence between software engineering and medical expertise, enabling smooth collaboration and measurable outcomes.
Do you have an out-of-the-ordinary project?
You need more than a vendor,
you need an ally.
Book a technical call with our team
Prefer a direct contact?
Email us at info@nrgsys.it