Pharmabiz

CDSCO releases final guidance document on Medical Device Software

CDSCO releases final guidance document on Medical Device Software: Gireesh Babu, New Delhi The Central Drugs Standard ...
Clayton Utz

Healthcare software: TGA clarifies when AI will be regulated as a medical device

Digital health innovators who use artificial intelligence (AI) must navigate a range of regulatory risks under Australia's medical device regime. To help them do so, the TGA has recently published ...
The Next Web

9 best requirements management tools for medical device development (2026)

Nine requirements management tools for medical device development ranked by traceability, compliance support, and regulatory readiness for FDA and EU MDR.
JD Supra

New MDCG guidance clarifies rules for medical device software available on online platforms

The Medical Device Coordination Group (“MDCG”) has issued guidance on the safe making available of medical device software (“MDSW”) apps on online platforms (MDCG 2025-4). MDCG 2025-4 outlines the ...
Medical Design & Outsourcing

How to Secure a Medical Device You Can’t Patch

By Joseph M. Saunders, Founder and CEO, RunSafe Security A medical device cleared today may stay in clinical service for 15 ...
JD Supra

CJEU Clarifies When a Healthcare Product Is a Medical Device Under the MDR: Beyond the Brochure

A blank plastic wristband rarely makes legal headlines. Yet on July 2, 2026, the Court of Justice of the European Union (CJEU ...