Stay updated on latest GMP trends through our webinars and articles

Medical device
Sumatha Kondabolu

Software Validation for Software as a Medical Device (SaMD): Ensuring Safety and Efficacy

Software Validation for Software as a Medical Device (SaMD) is a critical process that ensures the safety, efficacy, and regulatory compliance of software intended for medical purposes. Unlike traditional medical devices, SaMD operates independently of physical hardware, making its validation process unique and complex. This article delves into the key steps, regulatory requirements, and best practices involved in validating SaMD, providing valuable insights for developers, manufacturers, and regulatory bodies.

Do You Want To stay updated on latest GMP and pharma trends?

Join our webinars and events


Wait, don't leave empty-handed!​

Download our free Ultimate FMEA Guide, which is dedicated to GMP and pharma professionals.

This extensive yet simplified guide to Failure Mode and Effects Analysis (FMEA) will help you master one of the most vital instruments in your risk management toolbox.

GMP Ultimate FMEA Guide Qualistery

Weekly Industry Insights &
tips for success

Join thousands of pharma professionals on an enlightening journey. 

Subscribe to our weekly newsletter to stay current with the latest industry trends, compliance and skyrocket your career.