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…
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)External Link Disclaimer recognizes tha…
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,…
US FDA Substantial Equivalent Devices or Predicate Device in Medical Device Regulation bySCIENCE ARENA -March 08, 2024 The concept of substantial equivalent devices, often referred to as predicate devices, serves as…
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…