Medical Device & IVD Regulatory | SCIENCE ARENA

Quality Management System

Adverse Event Reporting: Ensuring Patient Safety in Medical Device and Drug Regulations

bySCIENCE ARENA -March 01, 2024

In this developing time of healthcare regulation, adverse events stand as critical indicators of…

CDSCO

Audit by Licensing Authority | Central Drugs Standard Control Organisation | Medical Device Rules 2017

bySCIENCE ARENA -February 07, 2024

In Order to regulate the medical device and IVD industry, the Govrenment of India introduced the…

CDSCO

Types of Licenses Granted by CDSCO in Respect of the Kind of Business in India under Medical Device Rules 2017

bySCIENCE ARENA -January 12, 2025

The Central Drugs Standard Control Organization (CDSCO) serves as the National Regulatory Author…

CDSCO

Clinical Investigation of Medical Device in India under Medical Device Rules 2017 (CDSCO)

bySCIENCE ARENA -August 06, 2024

Medical devices play a crucial role in healthcare, ranging from highly sophisticated systems lik…

Critical Flaws in India's Medical Device Approval System

bySCIENCE ARENA -April 22, 2024

India's medical device sector plays a crucial role in healthcare delivery, but recent conce…

US FDA

Medical Device Single Audit Program (MDSAP)

bySCIENCE ARENA -March 28, 2024

The International Medical Device Regulators Forum (IMDRF) recognizes that a global approach to a…

Quality Management System

Medical Device and IVD Certifications: How to Authenticate Valid Certificates and Authorized Certifiers ⌛

bySCIENCE ARENA -May 05, 2024

In the rapidly evolving landscape of the medical device and in vitro diagnostics (IVD) industry,…