Reliability & Functional Safety Services

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