Insights
Insights
Articles from Monica Burt and the MB&A team on medical device quality, audit readiness, regulation, and AI in quality. For new essays as they come out, read The Quality Signal at thequalitysignal.ai.
March 26, 2026 · AI in quality
You Don't Need to Fix Everything Before Deploying AI in Quality. Here's Why.
Quality risk doesn't pause while digital transformation runs. Why medical device quality teams can start audit intelligence now, without waiting for a three-to-five-year infrastructure overhaul.
March 26, 2026 · Audit readiness
From Audit-Ready to Audit-Intelligent: A Consulting Perspective on What the Industry Is Still Missing
Audit-ready means you can show compliance when asked. Audit-intelligent means you catch drift before an investigator does. What medical device quality teams are still missing, from hundreds of audits.
March 26, 2026 · Quality leadership
Future-Ready Quality: What High-Performing QA Teams Will Look Like in 2026
Part 3 of MB&A's Smarter Quality series: the QA/RA teams that succeed in 2026 grow through capability, digital fluency, and leadership, not headcount.
March 26, 2026 · Quality systems
Building a Lean, Compliant, and Audit-Ready Quality System
Part 2 of MB&A's Smarter Quality series: role clarity, mapped processes, document control, leaner internal audits, and shared supplier accountability for a medical device QMS that scales.
February 6, 2026 · Audit intelligence
Audit Intelligence: The Missing Layer in Your Quality Stack
Medtech digitized its quality systems but still runs risk identification on subjective, inconsistent audit data. What audit intelligence is, and why it is the missing layer in the quality stack.
November 19, 2025 · Quality leadership
Smarter Quality: The New Playbook for Scaling Compliance Without Adding Headcount
Part 1 of MB&A's Smarter Quality series: why the legacy medtech quality model is cracking, the hidden cost of quality, and why hiring more people doesn't fix it.
April 9, 2024 · Contract manufacturing
The CMO to CDMO Leap: Is There Another Path?
Contract manufacturers don't have to become full CDMOs to grow. A focused path into development services and regulatory support, and what FDA's QMSR changes.
March 27, 2024 · Quality systems
Why Contamination Control Matters in ISO 13485:2016 for Medical Device Manufacturers
What ISO 13485:2016 requires for contamination control, how to make it operational, and why it now matters for FDA inspections under the QMSR as well.
January 29, 2024 · EU MDR · Esra Barut
Periodic Safety Update Reports Under EU MDR: Best Practices for Device Manufacturers
What an EU MDR periodic safety update report must contain, how often it is due by device class, and practical ways to make PSURs repeatable. Updated for 2026.
February 13, 2023 · EU MDR · Amanda Rudd
The Case for MDR Extension, and What Happened Next
In 2023 we made the case for extending the EU MDR transition. The extension came with conditions. What changed, the deadlines that remain, and what to do now.
January 27, 2023 · AI regulation · Amanda Rudd
The UK's Outlook on AIaMD and the Need for Regulatory Improvements
What the UK Regulatory Horizons Council asked for on AI as a medical device, and how the MHRA has responded since, from AI Airlock to the National Commission.