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Medical Software Testing
Our team has 15+ years of experience in testing medical devices, both at hardware level and software level. Our processes and metrics follow the EU MDR (Medical Device Regulation) and the US FDA standards.
Medical software quality & compliance
Testing and documentation for regulated medical software.
15+ years of hands-on work on medical devices — hardware and software — with processes aligned to EU MDR and US FDA requirements. We test, we document, and we automate what should not be done by hand.
15+
years testing medical devices
EU MDR
and US FDA aligned processes
ISO / IEC
documentation built and maintained
