All articles from Sumatha Kondabolu

What is design control for medical devices and how does it work?

CDSCO registration: how to bring your medical device to India

The complete guide to SaMD (software as a medical device)

Navigating climate change: updates to ISO certification standards

What the FDA's MDDS guidance means for you

Everything you need to know about ISO 13485

What to look for in quality management consulting services in 2024

A comprehensive review of the best 21 CFR Part 11 software in 2024

How Much Is the FDA Medical Device Registration Fee in 2024?

QMSR: the FDA's plans to harmonize FDA 21 CFR Part 820 and ISO 13485 explained

21 CFR Part 820: the complete overview

The hidden costs of a free quality management system

The TGA's essential principles explained

The complete guide to passing ISO 13485 audits

510(k) submission checklist to get your medical device to market

The 3 FDA medical device classes: differences and examples explained

Complete guide to the MDSAP's nonconformity grading system

Understanding CAPA for medical devices: key concepts and requirements