All articles from Sumatha Kondabolu
Quality management
The hidden costs of a free quality management system
510(k)
510(k) submission checklist to get your medical device to market
FDA
The 3 FDA medical device classes: differences and examples explained
21 CFR Part 11
A comprehensive review of the best 21 CFR Part 11 software in 2023
Sumatha Kondabolu
Sumatha has 19 years of QA/RA experience across the medical device and pharmaceutical sectors.
She has built quality management systems for compliance with the FDA QSR, Canada’s Medical Devices Regulations, NIOSH, MDSAP, COFEPRIS, and the EU's MDR, IVDD and IVDR.
She holds a Master’s in Chemistry and an advanced certificate in quality assurance management, along with auditor certifications for ISO 13485, ISO 17025, ISO 9001 and IATF 16949.