Medical Device Regulations & Compliance

INDUSTRY PERSPECTIVES

  • Bacterial Endotoxin Testing, Part 1: Overview

    All injectable drug products and implantable medical devices that come into contact with the bloodstream or spinal fluid are tested for endotoxins. This article provides an overview of bacterial endotoxin testing and the LAL method.

Data-Driven Trends In Predetermined Change Control Plans

The FDA introduced the concept of the predetermined change control plan to address the dynamic nature of medical devices, particularly those using software and AI. Bridging Consulting conducted a data-driven study and shares the key findings.

Understanding The Potential Of AI Med Devices Amid Regulatory Challenges

As AI medical devices continue to evolve, collaborating with regulatory experts and embracing multidisciplinary approaches are crucial for navigating challenges and ensuring regulatory compliance.

Adaptive AI-Driven Medical Devices In The US: Regulatory Guidelines

This article delves in what is considered an adaptive AI-driven medical device and the current FDA regulatory considerations for them.

Is Mexico A Prime Location For Medical Device Clinical Trials?

Mexico, one of Latin America's largest economies and most populous countries, is emerging as a prime destination for medical device clinical trials and other advanced medical technologies.

WHITE PAPERS & CASE STUDIES

Eccentric Loading Test (Eccentricity) With External Test Weights

In many laboratories, weighing is a critical process. This operating procedure describes how to perform an eccentric loading test with external test weights.

One-Point Calibration With External Test Weights

This operating procedure describes how to perform a one-point calibration with external test weights, which is one of the recommended tests to ensure laboratory balances are working correctly.

Performance Test According To Chapter 2.1.7 Of The Ph. Eur.

This operating procedure describes how to perform a repeatability and sensitivity test according to Chapter 2.1.7. of the European Pharmacopoeia.

Repeatability Test With External Test Weights

A repeatability test with external test weights is one of the recommended tests to ensure balances are working correctly. This operating procedure describes how to perform a repeatability test with external test weights.

LATEST HEADLINES