The MAXM86161 module and its algorithm have not been validated for use in infants, necessitating self-validation to ensure suitability for measuring infant heartbeats and SpO2. For infants, the sensor should primarily be placed on the foot to measure heart rate and SpO2 using Red and IR LEDs. Medical certification is typically done at the system level, meaning the ability to qualify for certification by medical bodies will depend on the overall device design and the components used.