Medical Device Standards
Compliance & Verification Testing
Comprehensive standards compliance and verification testing for a medical device solution, validating functionality, reliability and compliance while preparing the product for external regulatory assessment.
Preparing a Medical Device for Regulatory Verification
GE HealthCare required comprehensive pre-certification testing before external standards assessment in Finland. AMSA focused on validating the medical device ecosystem, resolving defects and strengthening regulatory readiness.
Structured testing before external assessment.
AMSA established the verification strategy and test scope for the pre-certification process.
End-to-end validation across the device ecosystem.
Testing covered software, hardware, sensors, simulators and battery systems.
Defects resolved before regulatory submission.
Defects were tracked, corrected and regression-tested throughout the engagement.
Evidence prepared for standards verification.
Test results and compliance evidence supported final regulatory readiness.
Structured verification for regulatory readiness.
AMSA supported verification and validation across the medical device ecosystem, aligning testing activities with functional, safety and compliance requirements.
Verification Planning
Defined verification scope, test planning and traceable execution against applicable requirements.
System Testing
Functional, integration, regression and compliance testing across the complete device ecosystem.
Compliance Readiness
Verified defects, documented evidence and confirmed corrective actions before regulatory assessment.
Applying rigorous verification practices across the complete medical device ecosystem.
The engagement combined verification engineering, standards compliance and structured quality assurance methodologies to ensure the solution met functional, regulatory and reliability requirements before external assessment.
Verification & Validation
End-to-end V&V execution
Standards Compliance
Regulatory verification readiness
Functional Testing
System behaviour validation
Regression Testing
Continuous quality assurance
System Integration Testing
End-to-end ecosystem validation
Defect Verification
Resolution and revalidation
Verification & Validation
End-to-end V&V execution
Standards Compliance
Regulatory verification readiness
Functional Testing
System behaviour validation
Regression Testing
Continuous quality assurance
System Integration Testing
End-to-end ecosystem validation
Defect Verification
Resolution and revalidation
Risk-based Testing
Critical functionality prioritisation
Compliance Documentation
Traceable verification evidence
Firmware Validation
Version verification
Hardware Validation
Integrated device testing
Test Planning
Structured verification strategy
Quality Assurance
Reliable release readiness
Risk-based Testing
Critical functionality prioritisation
Compliance Documentation
Traceable verification evidence
Axone Server
Central server verification and system functionality.
Portrait Mobile Hub
Integration and communication validation.
Test Planning
Structured verification strategy
Medical Sensors
Clinical scenario and workflow validation.
Strengthening product quality and regulatory readiness.
AMSA's verification and compliance work helped prepare the medical device for external standards assessment while reducing certification risk.
Product Quality
Comprehensive testing identified and resolved significant issues before external assessment, improving product reliability and stability.
Regulatory Readiness
Structured verification, regression testing and compliance evidence strengthened preparation for standards verification.
Release Confidence
End-to-end validation increased confidence in the product's safety, performance and readiness for commercial release.
The product entered external verification with significant defects resolved and the required testing evidence established.
Combined expertise in artificial intelligence, data engineering and intelligent automation to transform traditional software testing into a scalable AI-powered platform, improving engineering efficiency, software quality and technical decision-making.