Operon Strategist

Common Issues in Defining the Intended Purpose of SaMD Overview

Software as a Medical Device (SaMD) can support diagnosis, monitoring, screening, treatment decisions, and clinical management without being part of a physical medical device. However, before determining its regulatory classifica...

Indian Medical Device Exports See Opportunities in High-Growth Markets

India has significant opportunities to expand its medical device exports as several international markets record strong growth in medical equipment imports. A recent study by India Exim Bank, a governme...

WHO Expands Prequalification Programme for Medical Devices, Contraceptives, and AI Tools Overview

The World Health Organization (WHO) has announced a major expansion of its WHO prequalification programme for medical devices. The updated framework widens the scope of quality-assured, sa...

How to Prepare an FDA PCCP for AI/ML-Enabled Medical Devices Introduction

Artificial intelligence and machine learning-enabled medical devices are different from many conventional medical devices because their performance may evolve through controlled software and model updates. 

This c...

Govt Proposes MDR 2017 Amendment to Empower CDSCO to Halt and Destroy Defective Devices

In a decisive move to strengthen market enforcement and safeguard patient safety, the Union Government is considering major changes to the Medical Devices Rules (MDR), 2017. The proposed amendment specifically ta...