Software validation and testing services for medical devices, including functional safety and security testing. Ensures medical device software meets regulatory requirements and operational standards.
Manufactured by
KCL
South Korea
As a GLP (Good Laboratory Practice) testing organization for human pharmaceuticals and medical devices, we have accumulated extensive testing capabilities supported by state-of-the-art equipment. We provide support for regulatory approval and certification of medical devices, chemicals, pharmaceuticals, and pesticides, and conduct a wide range of evaluations—from medical device testing and inspection to biological safety assessments using animals, microorganisms, and cell-based systems.
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Software Quality Systems S.A.
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Software Quality Systems S.A. · Spain
Software testing and validation services for medical devices, healthcare applications, and regulated laboratory systems. Specializes in verification and validation according to ISO, FDA, and EMA standards, including mobile health app certification and automated test process implementation.
Bluefruit Software Ltd · United Kingdom
Embedded software development and testing services for medical device manufacturers. Supports regulatory compliance, software validation, and quality assurance throughout the device lifecycle. Delivers scalable, maintainable code using Lean-Agile methodologies with rigorous testing protocols.
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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