Medical Device & IVD Regulatory | SCIENCE ARENA

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…

US FDA

FDA Medical Device Classification: A Guide to US FDA 😷Administration

bySCIENCE ARENA -December 08, 2024

Medical devices are integral to modern healthcare, ranging from simple tools like bandages to ad…

Biosafety Cabinets (BSCs): Types, Selection, and Best Practices 🦺

bySCIENCE ARENA -December 01, 2024

Biosafety Cabinets (BSCs) are critical laboratory devices designed to provide a controlled envir…

Medical Device

Preparing Regulatory Strategy for Novel, New, and Next-Generation Medical & IVD Devices

bySCIENCE ARENA -November 28, 2024

In the fast-paced world of medical and in vitro diagnostic (IVD) devices, the development of nov…

Medical Device

Miniaturization and Wearable Devices ⌚: The Future of Healthcare

bySCIENCE ARENA -October 25, 2024

The healthcare industry is experiencing a transformative wave of innovation, where miniaturized …

Biocompatibility

Biological Risk Assessment in Medical Device Risk Management 💀

bySCIENCE ARENA -October 03, 2024

Biological risk assessment is a crucial element of the broader risk management framework, parti…

Quality Management System

Optimizing ISO 13485 -- Documentation 📑for Efficient Quality Management System Implementation

bySCIENCE ARENA -September 15, 2024

ISO 13485:2016 mandates a range of documented procedures to ensure compliance and the consistent…