Medical Devices

Validation for medical device manufacturing

We help medical device manufacturers validate their facilities, equipment, processes and computerised systems, through thermal validation, CQV, clean room validation, computer system validation and bio-decontamination.

Our understanding of USFDA, EU GMP, EU MDR, WHO, PIC/S, TGA, ISPE and ISO standards comes from experience as production and QA personnel, and as auditors working within production and QC/QA environments.