Regulatory & Compliance
2026 Quality, Compliance, & Operations Trends Report Compare your quality, regulatory readiness, and operational performance against hundreds of your life sciences peers across MedTech, diagnostics, pharma, and biotech. What’s Inside the Report: Read the full report to see where your organization stands—and what’s shaping life sciences quality and compliance in 2026. Get the Free Survey…
Harmonization in Practice: What RA/QA Teams Must Do Before 2026 October 29, 2025 | Hosted by Grand Avenue Software As the FDA moves toward full implementation of the Quality Management System Regulation (QMSR) in February 2026, RA/QA teams are under pressure to understand what’s changing, what’s staying the same, and how to prepare their systems…
Why Modern Medical Device Manufacturers Can’t Thrive Without an eQMS: Five Reasons Digital Quality Systems Are Now a Competitive Necessity Nancy HansenGrand Avenue Software Medical device manufacturers operate in one of the most regulated, high-stakes industries. Every process, document, and decision ultimately ties back to patient safety—and outdated paper systems simply can’t keep up. A…
Risk Management for MDR: Extending Beyond ISO 14971:2019 Dr. Rachel Gibbs, PhD, BSc Medical device risk management is an iterative process that starts at the beginning of product development and evolves throughout the lifecycle of the device. Following the requirements set out in EN ISO 14971:2019 “medical devices – application of risk management to medical devices”,…
FDA Calls for ‘Secure-by-Design’ Cybersecurity for Medical Devices By Steve Zurier The Food and Drug Administration (FDA) has brought to light an age-old problem with medical IT systems: many are excessively vulnerable because they are based on legacy equipment from 20 or more years ago that were not built with cybersecurity in mind. In its…
ISO 13485: Understanding the Basics For medical device manufacturers, achieving ISO 13485 certification is essential for ensuring product safety, meeting regulatory requirements, and maintaining customer trust. As the international standard for Quality Management Systems (QMS) specific to the medical device industry, ISO 13485 provides a framework for managing processes, mitigating risks, and aligning with regulatory…
ISO 9001 vs. ISO 13485 Certifications for Medical Device QMS When implementing a Quality Management System (QMS) for your organization, understanding the differences between ISO 9001 and ISO 13485 is critical—especially for medical device companies. While both standards focus on quality management, ISO 13485 is tailored specifically for the medical device industry, while ISO 9001…
Understanding FDA Compliance for Medical Device Companies Bringing a medical device to market in the United States requires strict adherence to FDA regulations designed to ensure safety, effectiveness, and quality. The Food and Drug Administration (FDA) plays a critical role in overseeing medical device compliance, from classification and manufacturing practices to approval pathways and post-market…