Establishing an effective QMS based on ISO 13485, ISO 14971, IEC 82304 & IEC 62304 for Health Care, Medical Devices and SaMD, compliant to US FDA, HIPAA, EU MDR, GDPR & other regulations, including ESG (sustainability)

Establishing the appropriate organizational strategy & translating it into action, to achieve business goals and objectives, including an Integrated Process approach towards Quality standards, Regulatory compliance and Sustainability requirements

Designing and enabling deployment of processes towards an effective quality management system in organizations, with a focus on value addition to the business and alignment to strategic objectives

Facilitating compliance to US FDA, EU MDR and other country specific requirements, for Medical Devices, in tandem with Privacy and Information Security laws (HIPAA, HITECH, EU & UK GDPR and Indian IT Act) and ESG (India’s BRSR & EU’s CSRD)

Improve business productivity by eliminating waste and reducing process variations using the DMAIC - Define, Measure, Analyse Improve and Control and other 6 Sigma tools