BridgeMed Solutions can provide R&D testing, design specific test methods for your unique and novel prototypes. Our Testing Services are compliant with ISO 5840 Cardiovascular implants — Cardiac valve prostheses Standards as well as the FDA Draft Guidance for Industry and FDA Staff: Heart Valves – Investigational Device Exemption (IDE) and Premarket Approval (PMA) Applications 2010.
State of the art AWT
Our Accelerated Wear testing can:
- Test 1 – 6 Valves at a time
- High Performance Pressure Transducers
- Testing speeds Up to 50 Hz (3000 BPM)
- Achieve 200 million cycles in less than 50 days
- Up to 500 mmHg Differential Pressure
Dynamic Failure Mode
The Device Failure Modes
- Should be identified and well understood
- Are associated with structure deterioration
- Often done using Accelerated Wear Testing or Extraordinary loading.
- Can be further wearing a device past its target lifetime until failure.
Hydrodynamic Testing
Our Pulse Duplicator (PD) Machine can:
- Achieve flow rates between 1 – 10L/min & 2 – 240 BPM
- Simulate Mitral, Aortic, Tricuspid, & Pulmonary conditions.
- Precisely control and measure flow, pressure and temperature.
Glutaraldehyde Concentration Measurement
- Accurately test 0-3% Glutaraldehyde concentration
- Fast Results
- Affordable testing
Suture Pull Testing
- State of the art equipment
- Years of experience
- Many Successful Tests Performed
Ultimate Tensile Strength & Burst Strength Testing
- Capable of Up to 0.3MPa
- Able to Test Maximum Elongation
- Yield Strength Measurements
- Young’s Modulus Calculation
