EU AI Act for Medical Devices: 5 Key Obligations
The EU AI Act introduces a new compliance layer for AI-enabled medical devices in Europe. It requires manufacturers to meet both EU MDR/IVDR and AI Act obligations. High-risk AI medical devices must now address AI-specific requirements, such as data governance, risk...
CDSCO Regulations for Manufacturing Home Healthcare Devices
Home healthcare devices are medical tools designed for use at home to monitor, manage, and support health conditions. They are especially useful for elderly care, chronic diseases, such as diabetes or hypertension, and post-COVID recovery. In India, popular home...
What is QMS Certification Training for Medical Devices?
QMS certification training for medical devices is a professional course that teaches participants how to understand, implement, and audit QMS. The training typically covers regulatory requirements, risk-based thinking, documentation practices, and internal/external...