GUNDUA-HLANGANISA: COVID-19 DIAGNOSIS USING ASSEMBLING METHOD FOR IMAGERY

GUNDUA-HLANGANISA: COVID-19 DIAGNOSIS USING ASSEMBLING METHOD FOR IMAGERY

Design for ISO testing compliance

Transparent reporting of a multivariable prediction model for individual prognosis or diagnosis (TRIPOD): The TRIPOD is a guideline for developing and validating the AI model for COVID 19 diagnosis.

Carrying out clinical trials to demonstrate sensitivity, accuracy and specificity.

1) Testing patients using PT PCR tests and compare results with software results on the same patients sample
2) Compare success rate for tue positives and true negatives
3)Document findings using TRIPOD guidelines.

The ISO standards that underpin medical device regulation (by MHRA) and data handling are of a high quality and complement NHS Digital clinical risk management standards. ISO 13485, regarding quality management systems, helps give assurance that technology suppliers have good quality management systems and governance structures. ISO27001 gives guidance on handling and processing data. ISO 14971 covers risk management and ISO 62304 covers software lifecycle processes. British Standards Institute (BSI) is the UK National Standards Body and supports the development and publication of ISO standards.