Verification & Testing Services for Medical Devices
Your Partner in Active Medical Device Verification & Testing
We support bringing innovative active medical devices to market demands meticulous verification and testing to ensure safety, efficacy, and regulatory compliance. Our dedicated V&T services provide the objective evidence needed to confidently move through development and towards market approval. We specialize in the unique challenges presented by active devices, integrating electrical, software, and mechanical systems testing.
Our Verification & Testing Services
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Comprehensive Test Planning
Developing tailored V&T strategies aligned with your device requirements, intended use, and applicable regulatory standards (e.g., IEC 60601 series, ISO 14971, IEC 62304).
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Electrical Safety Testing (EST)
Verifying compliance with essential safety standards to protect patients and operators from electrical hazards compliant to IEC 60601-x series, with approved testing labs based on your budgets.
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Electromagnetic Compatibility (EMC) Testing
Assessing device performance in its intended electromagnetic environment and ensuring it doesn’t interfere with other equipment, compliant to IEC 60601-x series.
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Software Verification & Validation (V&V)
Rigorous testing of software components according to IEC 62304 and ISO 13485 requirements, including unit, integration, and system-level testing.
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Functional & Performance Testing
Confirming the device operates according to its specified functional requirements and performance criteria under various conditions, with traceability to requirements.
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System-Level Integration Testing
Evaluating the interaction and compatibility of hardware, software, and firmware components working together as a complete system.
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Usability & Human Factors Validation Support
Providing data through testing protocols to support the validation of user interface design and safe operation.
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Environmental & Durability Testing
Assessing device robustness and reliability under expected environmental conditions (temperature, humidity, transport, etc.).
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Detailed Documentation & Reporting
Providing clear, comprehensive test reports suitable for design history files (DHF) and regulatory submissions (FDA, EU MDR, etc.).
Partner with us for
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Specialized Expertise
Deep understanding of active medical device technologies and associated standards.
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Regulatory Focus
Testing designed to meet stringent international regulatory requirements.
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Risk Mitigation
Early identification and reporting of potential design or performance issues.
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Objective Evidence
Reliable, documented results to support your development and submission process.
Our Competence
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End-to-End Development
From idea conception to regulatory approval and manufacturing, we provide full-spectrum services.
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Experienced Team
Our experts bring deep knowledge and expertise in medical device design, engineering, and regulatory affairs.
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Innovation-Driven Approach
We focus on cutting-edge technology and process innovation to solve real-world healthcare challenges.
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Quality Commitment
We are dedicated to maintaining the highest standards in product quality, safety, and compliance.
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Customer-Centric Focus
We collaborate closely with our clients, ensuring that their specific needs and objectives are met at every stage of development.