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.

SaMD Regulatory Requirements

MedTech Insights

Global Software as a Medical Device (SaMD) Regulations Guide

Pujitha Dasari / June 8, 2026 / MedTech Insights

Software as a Medical Device (SaMD) is already part of many healthcare systems — from diagnostic tools to monitoring apps […]

Medical Device Submission Rejection Reasons

MedTech Insights

Why Medical Device Submissions Get Rejected (Expert Guide)

Pujitha Dasari / May 31, 2026 / MedTech Insights

Introducing a new medical device to the international market requires that you not only develop a new product, but manufacturers