The FDA Has Issued its Final Rule on QMSR; Adopts ISO 13485

On January 31st, 2024, almost a year after the Food and Drug Administration (FDA) published its proposed rule for the harmonization of quality system regulation (QSR) and ISO 13485, it has issued its final rule.  Here’s what medical device organizations need to know.  What Is QMSR? The quality management system regulation (QMSR), which has been a...

What Is an eQMS (and Why Life Sciences Organizations Need One)

The life sciences industry—from pharmaceuticals to biotechnology to medical devices—plays a pivotal role in ensuring global health. In order to do so, these organizations must comply with rigorous regulations and complex processes to ensure the products they deliver to market are at the highest standards of quality, safety and efficacy.  Organizations can effectively and efficiently...

Revolutionizing Complaint Management in Medical Device with AI-Integrated Quality Management Software

Introduction: In the fast-evolving landscape of the medical device industry, ensuring the highest quality standards is paramount. Complaint management plays a crucial role in identifying, addressing, and preventing issues related to product quality and patient safety. As technology continues to advance, the integration of artificial intelligence (AI) into quality management software solutions has emerged as...

Raising the Bar in Medical Device Compliance with Dot Compliance 

Welcome to the realm of regulatory excellence! In the intricate landscape of medical device manufacturing, regulatory compliance is not just a checkbox—it’s a commitment to ensuring the highest quality and safety standards. At Dot Compliance, we understand the pivotal role of compliance, especially with the stringent requirements outlined in 21 CFR Part 820. Navigating the...

Navigating FDA Compliance: A Guide to 21 CFR Part 210 and Part 211

In the pharmaceutical industry, ensuring the safety and quality of drugs is paramount. Manufacturers must adhere to stringent regulations set forth by the U.S. Food and Drug Administration (FDA) to meet the Current Good Manufacturing Practice (cGMP) standards.  For companies in the manufacturing, processing, packing, or holding of drugs, compliance with 21 CFR Part 210...

Unlocking Success: How the Right eQMS Can Be a Game Changer

In the highly regulated landscape of the life science industry, upholding uncompromising standards of quality is not just an option; it’s a necessity for achieving and sustaining success.  Whether you’re operating in the realms of pharmaceuticals, biotechnology, or medical devices, the quest to streamline operations, mitigate risks, and optimize efficiency is a constant pursuit.  Fortunately,...

The Evolution of Document Management Systems

Embracing the digital age, modern Document Management systems have evolved into powerful tools that streamline and enhance how organizations handle their crucial information.  In this era where efficiency, collaboration, and compliance are paramount, these systems have become indispensable for businesses across the life science industry. In this post we dive into the intricate components that...

How to Choose the Right eQMS – The Ultimate Guide

In the highly regulated life sciences industry, quality management is crucial for ensuring product safety, regulatory compliance, and operational excellence. Choosing and implementing the right quality management software is a strategic decision that can significantly impact your organization’s success.  This guide provides a step-by-step process to help life sciences professionals navigate the selection of quality...