Pujitha Dasari, Author at Artixio

Author name: Pujitha Dasari

Pujitha Dasari is a Regulatory Affairs professional with experience in compliance, technical documentation, gap assessments, labeling, UDI, and regulatory submissions across the EU, US, India, and other global markets. She focuses on translating complex medical device regulations into practical guidance for businesses entering and operating in international markets.

MedTech Insights

ISO 14971 Risk Management File (RMF) for Medical Devices

Pujitha Dasari / August 5, 2026 / MedTech Insights

Risk management is an important aspect in the development of medical devices. Performing risk management is a regulatory requirement in […]

MedTech Insights

510(k) Submission Process for Medical Devices

Pujitha Dasari / July 10, 2026 / MedTech Insights

A 510(k) is also referred to as a premarket notification, is one of the major pathways for bringing devices to

MedTech Insights

EU MDR/IVDR Post-Market Surveillance (PMS)

Pujitha Dasari / June 19, 2026 / MedTech Insights

Manufacturers are expected to have post-market surveillance as a component of their total quality management system. Post-market surveillance ensures the