Devices are Getting Smarter, Making Materiovigilance Evolve Faster

By Dr. Padmalakshmi Jnaneshwar

According to Deloitte, only 22% of life sciences leaders say they have successfully scaled AI, and just 9% report achieving significant returns. For materiovigilance, this highlights the growing gap between execution and team expectations. Within this gap, fragmented data and manual processes continue to slow response times and increase compliance risk, creating a disconnect between the promise of real-time safety monitoring and operational reality. How can organizations close this execution gap and evolve materiovigilance from a reactive compliance function into a proactive, data-driven discipline?

Continue reading →

Balancing Cyber Risk
Balancing Cyber Risk

What 524B and QMSR Change About Medical Device Risk

By Kaleb Averell

What 524B and QMSR actually require, in plain terms, including the post-market obligation that does not end at clearance? How both map to four kinds of exposure: cybersecurity, product liability, recall, and management liability. Where device makers are commonly unprepared against the new baseline, including the gap between cyber risk and product liability for software and devices.

Continue reading →

post market surveillance
post market surveillance

Why Organizations Miss Emerging Product Risk: Understanding the engineering mechanisms that remain hidden long before complaint trends become visible

By Aalap Patel, MS, CQE, CSSBB

Emerging medical-device risks are often missed because early warning signs are fragmented across complaints, manufacturing, suppliers, returned products, clinical observations, and other data sources; not immediately as statistically significant trends. An engineering-centered, cross-functional approach connecting these weak signals to underlying mechanisms sooner, can improve designs, verification, manufacturing controls, and risk management before isolated issues become widespread quality problems.

Continue reading →

post market surveillance
post market surveillance

From Compliance to Clinical Action: Fixing the Broken Loop in Post-Market Surveillance

By Aalap Patel, MS, CQE, CSSBB

Post-market surveillance (PMS) systems in the medical device industry have become increasingly sophisticated in collecting complaints, monitoring adverse events, and generating regulatory reports. However, many organizations still struggle to translate these insights into timely clinical action and meaningful patient safety improvements. This article examines the growing disconnect between regulatory reporting and operational decision-making, explores the challenges of signal detection and prioritization, and outlines practical strategies for building closed-loop PMS systems that improve patient safety outcomes and organizational responsiveness.

Continue reading →

AI Compliance in Medical Devices
AI Compliance in Medical Devices

Is Your Organization Ready to Govern AI in Regulatory Affairs?

By Anthony Watson, Geethapriya (Priya) Setty, Jay Vaishnav, PhD

By the time most medtech organizations noticed their teams were using AI in regulatory work, the governance conversation was already running behind.. How can your organization move forward? An Operational AI Capability Maturity Model — a five-domain framework built specifically for regulatory affairs and offers a direct way to assess where your organization actually stands. If your team cannot consistently answer who approved the tool, how the output was verified, and what was retained, this framework is a practical place to start.

Continue reading →

Managing AI in Medical Technology: From Innovation to Compliance

By Ali Behbahani, Dr. Ibrahim Halfaoui

Companies developing or deploying AI systems now face increasing scrutiny around risk classification, transparency and lifecycle governance. An AI management system (AIMS) aligned with ISO/IEC 42001 provides a structured way to address these challenges while significantly improving efficiency, quality, and innovation outcomes — and ensuring AI system are  effective, safe, compliant, and trustworthy.

Continue reading →