Medical Device & IVD Regulatory | SCIENCE ARENA

Events are Now Happening Go to Event Page All The Medical Devices Including IVDs are Now Regulated by Indian Government (CDSCO)| You Can Now View Individual Medical Device Data

Quality Management System

Quality Management System

Redefining Risk Management in Medical Device Manufacturing: Shifting Focus to Process-Based Risks

bySCIENCE ARENA -November 01, 2023

In medical device manufacturing, the focus on risk management has traditionally centered on prod…

Quality Management System

Corrective and Preventive Action (CAPA) – Process, Design, Stages and Application

bySCIENCE ARENA -October 22, 2023

Corrective and Preventive Actions (CAPA) are processes designed to improve quality and handle no…

Quality Management System

Balancing Act: The Curious Case of Clinical Evaluation in Healthcare Products

bySCIENCE ARENA -September 26, 2023

In the world of healthcare products, be it medical devices or medicines, the journey from incept…

Quality Management System

Elevating Healthcare: ISO and BIS Standards Unveiled for Medical Devices and IVDs

bySCIENCE ARENA -September 17, 2023

In the ever-evolving landscape of medical technology, manufacturers and regulatory bodies alike …

New

New Notifications from Regulatory Authorities

CDSCO: Circular for Licensing of Class C D medical devices
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CDSCO: Exemption of non sterile and non measuring Class A medical devices from licensing regime
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EU MDR: extension of the transitional periods for the application of the Medical Devices Regulation
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