Sumatha Kondabolu brings over 22 years of quality expertise across the pharmaceutical and medical device industries, specializing in quality system implementation and regulatory compliance for start-ups and scalable operations. She has helped organizations establish robust quality management systems aligned with global standards, enabling them to achieve seamless compliance and sustainable growth.
Sumatha has built and managed quality management systems meeting the requirements of FDA QSR, Canada’s Medical Devices Regulations, NIOSH, MDSAP, COFEPRIS, and the EU's MDR, IVDR, as well as pre-clinical and clinical frameworks. Her customers have successfully passed ISO and regulatory audits, achieving certification to the relevant ISO standards.
Sumatha holds a Bachelor of Pharmacy, a Master’s in Chemistry, and an advanced certificate in Quality Assurance Management. She is also a certified auditor for ISO 13485, ISO 27001, ISO 27701, ISO 42001, ISO 22716, ISO 17025, ISO 9001, and IATF 16949. Beyond certifications, she contributes to global standards development as an expert and committee member of the Standards Council of Canada (SCC)/ Canadian Standards Association (CSA) for:
- ISO/IEC JTC 1/SC 27 in Information Security, Cybersecurity, and Privacy Protection- Committee Member and Expert
- IEC TC 65/SC 65 as Technical Committee Member and Expert
- Chair for CSA Z289 and ISO/TC 210 - Quality management and related general aspects for products for health purposes, including medical devices.
