ISO 13485:2016, ISO 14971:2019, ISO 9001:2015, ISO 17025, ISO 14155, IEC 62304, IEC 60601 & MDSAP.

CGMP Auditing

We audit the existing and or new Medical Devices / IVD Manufacturing facilities to conform their compliance with the current GMP Standards of local and International Regulatory authorities viz:

CDSCO / MDR 2017

EU GMP (MDR 2017/745 & IVDR 2017/746)

US FDA

WHO