· ABOUT

Software, electronics & acoustics development.

ST-LINE is a software and electronics development company, founded in Padua in 2018 and based in Treviso since 2023. We design electronics, firmware and software for medical devices and precision instrumentation — from concept through CE marking and FDA clearance.

Who we are

We are a focused technical partner, not a generalist supplier. We work with a limited number of clients at a time, on complex problems in medical electronics, robotics and industrial instrumentation.

The experience behind ST-LINE

ST-LINE is founded and led by Stefano Fante: over thirty years of end-to-end design of electronics, firmware and software for certified medical devices, with specialization in low-noise analog acquisition, real-time systems, and cross-domain integration between electronics, optics and mechanics.

The company’s technical roots start here: co-founder and head of technology at Inventis (2005–2022), which he saw grow into a global reference in audiology and vestibular diagnostics, with medical devices brought to CE marking and FDA 510(k). Before that, ophthalmic diagnostic systems (Nidek) and industrial instrumentation. Since 2025, he also holds the qualification of Competent Acoustic Technician (ENTECA n. 12928).

We don’t tell this as a CV: it’s the reason why, when a client arrives with a complex problem, we already know what will happen 18 months later at certification.

Full biography →

Sectors we operate in

  • Certified medical devices — IEC 60601, IEC 62304, ISO 13485, MDR, FDA 510(k)
  • Precision instrumentation — low-noise analog acquisition, DSP systems, opto-electronics
  • Robotics and industrial automation — motor control, real-time systems, PLC integration
  • Environmental and architectural acoustics — Team of ENTECA-registered competent acoustic technicians, simulation and measurement

What sets us apart

  • We see the entire cycle, not isolated pieces

    From concept to schematic to PCB ink to firmware to software to CE marking. Every early decision shapes what happens 18 months later at certification — and those 18 months are ones we’ve already walked through, more than once.

  • We know the medical domain from the inside

    We’ve handled 20+ FDA / CE / international submissions (China, South Korea, LATAM). We know what a non-conformity means in audit and how to prevent it at the architecture level.

  • Proprietary DMS/QMS for regulatory submissions

    For clients who need it, we provide our internal document and quality management system (Alfresco + OpenProject + Wiki.js), designed to support MDR, FDA 510(k), ISO 13485 submissions — with a risk matrix auto-generated from linked documents.

  • AI built into products and projects

    LLM models, local agents, on-prem pipelines (Ollama, Claude API, Llama). These are technologies we master and integrate directly into our clients’ products — from network data classification to predictive diagnostics, up to documentation and regulatory workflow automation.

  • Instrumentation for EMC debug and pre-compliance

    Spectrum analyzer, signal and function generators, current and differential probes, oscilloscopes. They let us anticipate EMC issues internally and reduce pre-compliance cycles at accredited labs.

We do not substitute accredited EMC labs for final compliance.

To us, engineering is the synthesis of method, experience and curiosity: technical quality comes from the balance between design rigor and adaptability. We keep exploring new fields — from embedded electronics to artificial intelligence — with the same mindset as always: building solutions that are solid, understandable, and of real value.

— Stefano Fante, founder

Let’s talk about your project.

From concept to certification, with a single technical partner.

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