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 syst...
Manufactured by
Software Quality Systems S.A.
Getxo, Spain
Software consulting and QA testing Ensure quality and compliance with requirements and standards of your software systems and products Extensive experience in both safety-critical systems and regulated environments as well as non-commercial applications. SQS invests considerable effort in its research and development department every year. The motivation to research new processes, methods and tools in the area of software quality and testing is the driving force behind this activity within the company.
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REVOLVE HEALTHCARE Sp.z.o.o./s.z.o.o.
Poland · 2 relevant products
KCL
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REVOLVE HEALTHCARE Sp.z.o.o./s.z.o.o. · Poland
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 architecture for medical software solutions.
KCL · South Korea
Software validation and testing services for medical devices, including functional safety and security testing. Ensures medical device software meets regulatory requirements and operational standards.
BROADSIMS Inc. · Taiwan
A software tool for automatic verification of medical devices against regulatory standards including YY, JJG, and IEC requirements. Supports quality assurance and compliance validation throughout device lifecycle.
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