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Medical Device Engineering

From concept to certified, production-ready medical devices

We design and develop connected medical devices with the rigor, safety and traceability required by ISO 13485 and CE marking. Our multidisciplinary engineering process integrates sensing technologies, electronics, firmware, wireless connectivity, usability, cloud platforms and manufacturing transfer.

Engineering aligned with medical compliance from day one

Medical devices require more than good engineering — they require documented processes, validated technologies, risk management, usability evidence and verifiable product quality. Sterna integrates these elements from the first concept to ensure safer development and faster certification.

Medical Product Design & Usability

We design devices around clinical needs, workflows and safety:

  • Requirements definition and user needs
  • Usability engineering (IEC 62366)
  • Human factors and risk-driven design
  • Mechanical, ergonomic and environmental integration

Electronics, Sensors & Firmware

We turn sensing technologies into reliable, medically safe hardware:

  • High-precision sensors and digitalization
  • Low-power embedded electronics
  • Secure firmware design
  • BLE, WiFi, NB-IoT, LTE-M, LoRa connectivity
  • Power optimization and battery strategy

Safety, Compliance & Documentation

We prepare every device for CE certification:

  • ISO 13485-aligned development
  • Risk management (ISO 14971)
  • Electrical safety (IEC 60601)
  • Verification and Validation (DVP / V&V)
  • Design History File (DHF) and Device Master Record (DMR)

Cloud, Data & Traceability

We build secure digital layers for medical devices:

  • Backend, APIs and data pipelines
  • Dashboards for clinicians and administrators
  • Traceability, alerts, patient/device logs
  • Edge/on-premise solutions for hospitals
  • Cybersecurity and privacy-aligned architecture

STERNA
INNOVATION

When to work with us

We support MedTech teams that need a partner capable of guiding them through the technical, clinical and regulatory challenges of developing a connected medical product. Whether starting from concept or improving an existing prototype, we focus on reliability, safety and compliance.

  • Your product integrates sensors, electronics and wireless connectivity
  • You need ISO 13485-aligned engineering and documentation
  • You must obtain CE marking or prepare a regulatory file
  • You require usability and human-factors engineering
  • Your device will be deployed in clinical environments
  • You need a single partner from prototype to manufacturing

Medical startups we support:

Frequent Asked Questions

“Do you work under ISO 13485?”

Yes. Our processes align with ISO 13485 and ISO 14971, and we build all documentation needed for certification and audit readiness.

“Can you support CE marking?”

Yes. We prepare technical files, risk documentation, labeling and verification evidence required for CE marking.

“Do you integrate with hospital IT systems?”

Yes. We design secure connectivity, dashboards and integrations for clinical workflows.

“Can you handle manufacturing transfer?”

Yes. We support DFM, tooling, pilot runs and quality processes until full production.

Let’s build your next medical device

From concept to certified product, we help you reduce risk, accelerate
development and deliver meaningful medical technology.

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