All articles from Sumatha Kondabolu
FDA
The 3 FDA medical device classes: differences and examples explained
Medical Devices
What is design control for medical devices and how does it work?
Compliance
CDSCO registration: how to bring your medical device to India
ISO 9001
Navigating climate change: updates to ISO certification standards
Quality-Driven
What to look for in quality management consulting services in 2024
21 CFR Part 11
A comprehensive review of the best 21 CFR Part 11 software in 2024
Medical Devices
How Much Is the FDA Medical Device Registration Fee in 2024?
Medical Devices
QMSR: the FDA's plans to harmonize FDA 21 CFR Part 820 and ISO 13485 explained
Quality management
The hidden costs of a free quality management system
510(k)
510(k) submission checklist to get your medical device to market
Medical Devices
Understanding CAPA for medical devices: key concepts and requirements
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.