Medical Device Mechanical & Performance Testing Laboratories
Performance testing shows the device does what it claims, safely, through its life. Programmes are device-specific and often follow device-specific standards, FDA guidance or special controls. Typical work includes: catheters and tubing — tensile and bond strength, kink, burst, leak and flow; connectors — small-bore connector (ISO 80369 series) performance; needles and syringes — penetration, bond and dimensional tests; guidewires and stents — flexibility, fatigue and corrosion; orthopaedic and dental implants — static and fatigue testing and wear.
What does it measure?
- Tensile, compression, flexural and torque
- Bond and joint strength
- Burst, leak and flow
- Fatigue and durability
- Wear and friction
- Simulated use
- Dimensional and metrology inspection
When is it used?
- Design verification
- Supplier and process changes
- Supporting premarket submissions
- Investigating field complaints
Sample considerations
- Test finished, sterilized and, where relevant, aged devices.
- Name the device-specific standard or guidance you are working to, if known.
Laboratories with relevant capabilities
- Element Materials Technology (Aberdeen, Scotland) — Materials Testing, Mechanical Testing, Metallurgical Analysis
- Laboratory Testing Inc. (Hatfield, PA) — Materials Testing, Mechanical Testing, Chemical Analysis
- IMR Test Labs (Ithaca, NY) — Materials Testing, Chemical Analysis, Metallurgical Analysis
- Westmoreland Mechanical Testing & Research (Youngstown, PA) — Mechanical Testing, Materials Testing, Fatigue & Fracture
- Touchstone Testing Lab (Triadelphia, WV) — Mechanical Testing, Fatigue & Fracture, Materials Testing
- Anderson Materials Evaluation (Columbia, MD) — Surface Analysis, Materials Testing, Failure Analysis