Medical Device & IVD Regulatory | SCIENCE ARENA

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,…

Quality Management System

Standards and Certification: Identifying Certifiable & Non-Certifiable Standards

bySCIENCE ARENA -March 06, 2025

In today's globalized and highly competitive world, standards play a crucial role in ensurin…

Audit

Certification Audit - an auditee's perspective

bySCIENCE ARENA -February 05, 2024

Certification audits play a pivotal role in ensuring that organizations comply with established …

Quality Management System

Understanding and Determining the Scope in a Quality Management System

bySCIENCE ARENA -December 11, 2024

This article explores the various definitions and contexts of "scope" in a Quality Ma…

Quality Management System

Manufacturing Facility 🏭 Requirements for Medical Devices 📑

bySCIENCE ARENA -May 14, 2024

The journey from concept to product in the medical device industry involves attention to detail …

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

Building a Solid Foundation: Exploring the QMS Family Standards for Effective Quality Management

bySCIENCE ARENA -June 23, 2023

In the dynamic and highly regulated business landscape, organizations strive to ensure the highe…

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…