Skip to main content

Performance and Function Testing

Technical documentation must demonstrate the device performs as intended:

  • Bench testing — mechanical, physical, functional performance
  • Analytical performance (IVDs) — accuracy, precision, linearity, reference range
  • Biocompatibility (ISO 10993 series)
  • Shelf life / stability — real-time or accelerated aging
  • Sterilisation validation (for sterile devices)
  • Software verification and validation (for software components)
  • Usability testing — human factors, especially for lay users

Test reports from MFDS-recognised testing laboratories required for standards-mandated tests.