EMBEDDED SOFTWARE

The Code that drives our world.

FLORIAN KUBALA • EMBEDDED SOFTWARE ENGINEER

Services.

ACCELERATING SAFE & CONNECTED MEDICAL DEVICES.

Turning complex hardware and strict regulatory requirements into reliable, audit-ready medical products.
01. AUDIT-READY FIRMWARE & REGULATORY COMPLIANCE.
  • De-Risked Approvals: Development of safety-critical firmware aligned with IEC 62304 and EU-MDR from day one – preventing costly rework ahead of audits.
  • Bridging R&D and QA: Translating strict regulatory requirements into pragmatic engineering workflows, clean traceability, and clear Software Architecture Design.
  • Dependable System Integration: Safe integration of third-party software and multi-core systems with a sharp focus on fault tolerance and stability.
02. SCALABLE ARCHITECTURE & RAPID TIME-TO-MARKET.
  • Future-Proof Software Foundations: Designing modular, maintainable architectures (leveraging modern ecosystems like Zephyr RTOS) that scale across product generations.
  • Fast Hardware Bring-Up: Getting new custom boards operational quickly and reliably – unblocking hardware and application teams early in the project lifecycle.
  • Resource & Power Optimization: Maximizing battery runtime and deterministic real-time behavior on constrained embedded hardware.
03. SECURE CONNECTIVITY & QUALITY ASSURANCE.
  • Security by Design: Embedding robust cybersecurity into connected devices from the ground up – protecting patient safety and meeting modern regulatory expectations.
  • Reliable Ecosystem Connectivity: Ensuring seamless, dependable data exchange between medical devices and surrounding digital ecosystems in demanding clinical or home environments.
  • Scalable Quality Assurance: Replacing time-consuming manual checks with automated verification – catching regressions early and accelerating release cycles from R&D to production.

Qualifications.

CERTIFICATIONS & TRACK RECORD.

15 years of embedded software engineering backed by recognized industry certifications.
01. CERTIFICATIONS & ACADEMIC BACKGROUND.
  • Dipl.-Ing. (FH) Technische Informatik (Computer Engineering) – TH Mittelhessen (2010)
  • iSAQB® CPSA-F – Certified Professional for Software Architecture (2024)
  • CPMS – Certified Professional for Medical Software (2022)
  • TÜV Safety Expert – Active Medical Devices (2017)
02. INDUSTRY EXPERIENCE & TRACK RECORD.
  • 15 Years in Software Engineering: Over 10 years dedicated to embedded software for active medical devices.
  • Proven Regulatory Track Record: Hands-on contributions to successful FDA and CE clearances as well as external cybersecurity audits.

Contact.

LET’S TALK.

You want to get in touch with me? Just drop me a line below.