Medical Device Testing
Ensuring Quality and Compliance with Comprehensive Medical Device Testing.
Our services for medical device clients cover every aspect of the development process, from proof of concept testing to lot release testing, to ensure your device is safe and reliable.
We offer device characterisation, reliability testing, device verification, and validation services to ensure that your device meets all necessary standards.
Device Characterisation
Deep Dive into Device Characterisation: Assessing Component Performance & Interaction
Our device characterisation services help you to:
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Gain insight into the behaviour of components and parts.
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Confirm that all elements work together seamlessly
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Evaluate potential areas for improvement and optimization.
Verification & Validation
We're dedicated to ensuring that your medical device works correctly and is built to last.
Our verification & validation services include:
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Verifying correct operation of the device and components
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Validating the accuracy of the device's construction.
Released Product
Unbiased Testing Solutions for a Wide Range of Products.
We provide impartial testing services for all types of products, including:
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Lot release testing to ensure quality control
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Complaint investigation to address any issues.
Device Verification & Validation Service
Our team operates within our certified ISO13485 quality management system and cutting-edge testing labs for seamless testing to your product requirements.
01
Planning
Streamline your design verification and validation process with our expert planning services.
Our team partners with your senior engineers to create and manage a comprehensive plan, defining what will be measured and how, so that your team can focus on development.
02
Developing
Simplify the Verification & Validation process with our expert support.
Our team will work with you to define the best approach, write and approve test cases, and ensure accurate measurement through Method Design and Test Method Validation.
Let us handle the details while you focus on product development.
03
Executing / Lab testing
Test procedures are executed in our verification and validation labs.
Any invalid results are documented and reviewed, and either accepted or logged as defects. From test execution, Defects are tracked and root cause analysis to trace matrix management.
We aid your team with experienced testers to ensure all testing is completed as planned.
04
Reporting
Reporting is performed at the end of each phase of verification & validation.
Detailed reports include release reports, test results by testing type or product version, and issues found during the verification/validation activity.
We work with QA, R&D and SME’s to create, compile and review all technical reports prior to design review.
Our Support Services
We work with you across all components of device testing in 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.
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