Customized Stent Fatigue Tester: Technical Features
- Customizable accelerated fatigue testers built to client specifications
- Direct device strain measurement: Ultrasonic (US) dynamic displacement, laser micrometer, high speed camera
- Direct device frequency measurement: Ultrasonic (US) dynamic displacement, laser micrometer, high speed camera
- Number of cycles monitoring
- Fatigue Tester frequency monitoring
- Fatigue Tester temperature monitoring
- Fatigue Tester provided with full IQOQPQ plan and documents
- Fatigue Tester provided with full instructions manual
Customized Stent Fatigue Tester: Scope
- Tailored solutions for medical device fatigue testing
- Any medical device requiring accelerated fatigue testing
- Any cardiovascular device susceptible to fatigue failure
Customized Stent Fatigue Tester: Applicable standards
- ANY MEDICAL DEVICE SPECIFIC STANDARD REQUIREMENTS
- GLP STUDIES PER CODE OF FEDERAL REGULATIONS CFR21, PART 58 - GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIES
Customized Stent Fatigue Tester: Associated tests
- Medical Device pre-conditioning
- Optical Inspection
- Scanning Electron Microscopy (SEM)
Customized Stent Fatigue Tester
ISO 13485 certified engineering solutions for medical device fatigue testing . Our engineers can design fatigue test equipment and solutions tailored to specific device fatigue requirements. Our solutions include equipment, dedicated device fixture, full fatigue tester validation plan with corresponding documentation: test protocols, test procedures, test reports, IQOQPQ protocols and plan. Fatigue testers can be delivered and installed on site or operated by our staff in our facility.