IT Regulatory Spark

ABOUT

Twenty years where product, quality and regulation had to work together

Most consultants work on a single layer: the engineer who doesn't read regulations, the lawyer who has never seen firmware, the trainer who has never shipped a product. The result is familiar: disconnected pieces that someone in your company — usually you — has to hold together.

I work at the intersection. I'm a telecommunications engineer with an MBA. I founded and led a medical device startup for eight years, taking it from prototype to FDA 510(k) and CE certification. Today I work on AI, cybersecurity and EU regulation applied to industrial products.

I don't write documentation for audits. I help people who design and decide to integrate regulatory requirements and security into product decisions — architecture, development, roadmap — because that's where compliance is actually built.

Alberto Scarpa

HOW I WORK

Three principles, no exceptions

Decision-driven, not audit-driven

The endpoint isn't the document that satisfies the auditor. It's the product decision made knowingly: which architecture, which supplier, which roadmap priority.

On the product, not on paper

Late compliance always costs more. It's not a prediction — it's what I see in every project. That's why I work with R&D teams at design time, not on a finished product.

Business language and standards language

I speak both and translate one into the other: to the board I bring measurable risks and returns, to designers applicable requirements. No academic jargon in between.

PATH

From embedded systems to the boardroom

I've written code, designed architectures, managed FDA audits, raised capital and negotiated with distributors. This sequence isn't common — and it's exactly what it takes to translate a regulation into a design choice.

  1. 2024 — PRESENT IN PROGRESS

    Independent consultant — AI Strategy & Cybersecurity

    AI roadmap and governance, ISA/IEC 62443 assessments, gap analysis and CRA and RED compliance paths for manufacturers of embedded systems and Industrial IoT. Training for R&D, IT and management teams.

  2. 2024 — PRESENT IN PROGRESS

    Co-founder & Head of AI — Eyes.guru

    AI/MedTech startup for the intelligent analysis of clinical eye images.

  3. 2022 — PRESENT IN PROGRESS

    Product Manager — DAVE Embedded Systems

    Product Manager of ToloMEO, a fleet-management platform with industrial IoT, edge AI and embedded cybersecurity. Security architectures for connected devices (CRA, RED, IEC 62443). WP Leader in the European project Prometeus (EIC Pathfinder).

  4. 2015 — 2023

    CEO & Founder — D-EYE

    Smartphone-based medical devices for ophthalmic diagnostics, from prototype to global commercialization: FDA 510(k), CE Mark, over €1.5M raised between VC and Horizon 2020. ISO 13485 quality system, regulatory audits, validation of software and AI systems.

  5. 2007 — 2017

    Project Manager & Software Architect — M31 / Si14

    Complex systems for healthcare, industry and energy: distributed software architectures, IoT platforms, coordination of multidisciplinary hardware, software and safety teams.

CERTIFICATIONS AND EDUCATION

COMMITTEES AND APPOINTMENTS

Scientific publications on computer vision and medical image analysis →  Google Scholar

The fastest way to find out whether I can help you

A free 45-minute call: we map your actual regulatory exposure and you leave with a written summary and a recommended direction. If I'm not the right person, I'll tell you.

Book the Regulatory Spark

Or find me on LinkedIn