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Functionality Testing
Medical Device Functionality and Bench Testing
Whether your objective is CE marking, a submission to the FDA, benchmarking or marketing-support data, we are able to assist you. Our ISO 9001-2008 certified laboratory is run by engineers with a minimum of 15 years experience in the medical device industry, who can even participate in your Risk Analysis and process FMEA (Failure Mode and Effects Analysis) to ensure that correct data is available to support your product claims.
We implement programmes to assess products against either:
- The relevant consensus standards (ISO, CE etc.)
- Our client's own testing protocol
- An MET-designed testing protocol that addresses your specific concerns
Our tests at a glance:
Excellence in Medical Device Testing
- Product functionality
- Verification of key product claims
- Risk analysis challenge
- Investigation of customer returns/feedback
- Comparative studies
Recent projects include:
- Materials stability studies
- Proving the effectiveness of sterile barriers
- Leak and flow studies
- Simulated use and ease of use
- Bond integrity and strength studies
- Stability testing in various environmental conditions
- End users complaints analysis
Vascular Devices
Our vascular device testing services encompass a broad range of equipment and expertise for Proof of Principal (POP) testing and design verification to ISO standards and/or special programs. We can test devices such as endovascular products, interventional devices and all manner of implants, delivery systems, balloons and guide wires... Vascular Devices read more...
Orthopaedic Devices
MET offer expert analysis of orthopaedic implants for strength and fatigue testing, wear and degradation studies. Finite Element Analysis (FEA) and physical evaluation is performed on rigid, soft and bio-absorbable implants. Package testing and ageing studies compliment joint replacement performance studies... Orthopaedic Devices read more...
