Rigorous Testing Capabilities for Next-Level Medical Devices
TESTING
SUPPORT IN..
Ensuring Safety, Efficacy, and Market Success with Comprehensive Testing ServicesOur team operates within our certified ISO13485 quality management system and cutting-edge testing labs for seamless testing to your product requirements.
VERIFICATION & VALIDATION
Certifying Performance, Safety, & Compliance:
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Confirm Design Specifications:
Through verification, we ensure that your device meets all outlined design specifications and functionalities.
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Validate Clinical Efficacy:
​Our validation tests confirm that your device performs as intended in a clinical setting, ensuring safety and effectiveness.
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Streamline Regulatory Submissions:
​We generate comprehensive reports that facilitate smoother regulatory submissions and approvals.
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Minimize Risk:
​Our rigorous testing procedures identify and mitigate potential risks, ensuring a safer and more reliable product.
SUPPORT
OUR
Supporting Testing services to advance your medical product development..
Requirement Reviews
Working with your development teams to refine and check the requirements for omissions on testable requirements.
Protocol and method development
Creating bespoke test methods against your established acceptance criteria suitable for intended use.
Test Method Validation
Validation of your or our method to ensure the test is suitable for its intended purpose.
Result Analysis
Reviewing and conducting statistical analysis on data generated as defined within test plans or test methods.
Test plan Generation
Using your requirements to Build verification and validation test suites for your product.
Packaging & Transport Validation
Validation of your primary, secondary and final packaging solution to international standards.
Measurement system analysis
Assessment of any and all measurement systems which may be used in development.
Anomaly Investigation
Conducting engineering investigations into any issues identified during testing.
Test Rig Generation
Creating, designing and validating test rigs for experimental use.
Cleaning & Sterilisation Validation
Working with you to develop and implement robust cleaning and sterilsation validation activites for your device.
Test Execution
Conducting and executing defined tests using our internal labs and technical team.
Report Generation
Generating development reports for quality review and compliance.