3 Challenges Faced by Life Sciences Organizations Without an AI-Powered eQMS

Quality is critical in any organization. Within the life sciences industry, where low quality can result in dire consequences for patients, a high level of quality is non-negotiable. Technology advancements like AI-powered electronic quality management systems (eQMS) are making quality more intuitive and enabling a predictive and proactive approach to quality management.  Manual or paper-based...

What to Know about IEC 62304 and Why It’s Important for SaMD

Digital transformation has ignited a change in the medical device industry, one that leverages technology to create life-saving devices. Not just as a component of a medical device but as the medical device itself. This clear distinction is what’s known as Software as a Medical Device (SaMD).  The International Medical Device Regulators Forum (IMDRF) defines...

The Impact of Generative AI in the Life Sciences Industry

The use of digital technologies has become the standard within the life sciences industry, and the digitalization of data has facilitated the adoption of artificial intelligence (AI). The pace of this technology adoption has only continued to accelerate.  The U.S. Food and Drug Administration (FDA) has embraced the use of AI in FDA-regulated products, stating:...

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...