Reliability & Functional Safety Services
SGS provides reliability testing services to assist you in designing high-reliability and high-quality medical device. SGS also provides regulatory verification services to make your products comply with regulatory requirements, promote medical device to enter the market faster, and enhance the company value
![Reliability & Functional Safety Services](https://www.sgs.com.tw/images/cgcustom/f1200159247742190.png)
Medical Device Software Verification and Validation
- IEC 62304 : Software life-cycle processes
- FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices
- IEC 60601-1 Clause 14 Programmable Electrical Medical System
Medical Device Regulatory Validation Service
- IEC 60601-1-8 General requirements for basic safety and essential performance - General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
- IEC 60601-1-11 General requirements for basic safety and essential performance - Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
- IEC 62133 Medical Device secondary cells and batteries safety requirements
- UN38.3 Medical Device lithium batteries UN transportation Tests
Medical device environmental and reliability testing service
- ASTM D4169 / ISTA packaging and transportation test
- Storage test / Bounce test / Withstand Voltage test / Drop test / Vibration test
- IEC 60529 Degrees of protection provided by enclosures (IP Code)
- IEC 60721 : Classification of groups of environmental parameters and their severities
- Transportation Environment Simulation / Storage Environment Simulation / Indoor Environment Simulation / Outdoor Environment Simulation / Vehicle Environment Simulation / Ship Environment Simulation / Portable Product Environment Simulation
- IEC 60068-2 series of specifications for environmental test methods for electronic products
- Temperature/ Humidity Cyclic Testing/Thermal Shock Testing/Salt Spray Testing/Altitude Test/Solar Testing/Vibration Testing/ Shock Tests/ Impact Shock
- Medical device mechanical/physical testing
- Button / switch / connector durability test / bending and torsion test / voltage withstand test
- Medical device chemical solvent resistance test / sweat and saliva resistance test
- Medical device noise test-sound pressure and sound power measurement
Reliability Consulting Service
- MTBF - Life Test
- MTBF Prediction / Accelerated Life Testing
- Failure Modes and Effects Analysis - FMEA
- PCB reliability verification / Component and Solder Joint Quality Verification / Solder Joint Section Microscopic Observation / X-Ray / C-SAM / SEM / EDS and other observation and analysis