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

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

 

Reliability Lab - Taipei
TEL
(02) 2299-3279  #3611~3616
FAX
(02) 2299-9558
ADD
No.31,Wu Chyuan Rd., New Taipei Industrial Park,Wu Ku Dist., New Taipei City 248016, Taiwan
Reliability Lab - Functional Safety
TEL
(02) 2299-3279  #3660, 3661
FAX
(02) 2299-9558
ADD
No.31,Wu Chyuan Rd., New Taipei Industrial Park,Wu Ku Dist., New Taipei City 248016, Taiwan