End-to-end software development service for medical devices, from concept through CE certification. Delivers mobile, desktop, web, and integrated applications compliant with ISO 13485, IEC 62304, MDR, IVDR, and FDA standards. Supports regulatory documentation, product design, and scalable architectu...
Manufactured by
REVOLVE HEALTHCARE Sp.z.o.o./s.z.o.o.
Katowice, Poland
We re Revolve Healthcare, an ISO 13485 certified medical software development company established in 2015. With over 50 experts, we provide end-to-end services for building medical products: from defining intended use through product design, software engineering and CE certification. Our commitment to excellence is reflected in compliance with standards like MDR, IVDR and FDA.
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Software Quality Systems S.A. · Spain
Software validation and verification platform for medical device development, ensuring compliance with ISO, EMA, and FDA regulatory standards. Provides independent V&V services, automated testing automation, mobile health app validation per ISO 82304-2, and performance testing for healthcare IT systems in regulated environments.
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