MedTech Leading Voice newsletter, issue 171

AI Governance and the Future of Regulatory Expertise

Published 6 July 2026Author Sean SmithIssue 171

AI governance moved from principle to practice this week. The EU AI Act amendments and the updated IEC TC 62 standards list for AI-enabled devices both point in one direction, and Barbara ...

MedTech Leading Voice | Issue 171

📝 From the Editor

AI governance moved from principle to practice this week.

The EU AI Act amendments and the updated IEC TC 62 standards list for AI-enabled devices both point in one direction, and Barbara Pirola's case for lifecycle-based governance shows what operating inside it looks like. The questions we hosted on July 3 about the human expert's place in that shift feel more concrete as a result.

— Sean Smith

🧠 Featured Post

Cybersecurity Testing Gaps in AI-Enabled 510(k) Submissions Jason Sinchak examined the cybersecurity testing gaps that surface in 510(k) submissions for AI-enabled medical devices. His focus is the distance between what a submission states about security and what the testing behind it actually covers.

For MedTech teams, this is a premarket problem before it is a postmarket one.

When an AI-enabled device submission carries a testing gap, reviewers find it, and closing it after a deficiency letter costs more than building the coverage in from the start.

View the post >>

📌 This Week's Top Posts (In no special order)

Tibor Zechmeister detailed root cause analysis tools for effective CAPA investigations.
Updates to the EU MDR well established technologies regulations, announced by Mario Gabrielli Cossellu.
Jason Sinchak discussed cybersecurity testing gaps for AI enabled medical device 510(k) submissions.
Key quality management lessons from the FDA warning letter issued to ZOLL Medical, overviewed by Susan Leister.
In her weekly Monday News, Marina Daineko highlighted key MedTech regulatory updates on FDA non animal testing, data integrity, EU COMBINE, and WHO sustainability.
Stefano Bolletta summarized regulatory challenges facing micro and small medical device manufacturers under the EU MDR and IVDR.
Lifecycle-based AI governance and implementation in regulated environments, reviewed by Barbara Pirola.
Katri Harjulehto compiled key updates to the EU AI Act following the latest amendments.
Updated IEC TC 62 list of suitable standards for AI enabled medical devices, underscored by Regina Geierhofer.
Feroz Khan examined the role of cybersecurity in protecting medical devices and patient safety.
Kiran Kumar Prabu shared a new infographic explaining the European Regulatory Affairs ecosystem.
EN 60601-1 is harmonised under the MDR by Leo Eisner.

🎯 Featured Event Friday In-Focus

When AI Replaces Regulatory Professionals: What Happens Next?

Join me and Marcus Emne, founder of Compliance Studio, for a Friday in Focus conversation on what AI means for the future of Regulatory Affairs. AI has already moved from a future discussion to a weekly reality, with some teams cutting costs and speeding up work while others struggle to see where it actually creates value. Regulatory work is no exception, and tasks that used to take real manual effort can now be done faster and cheaper.

So the question we're taking on is a people question, not a technology one: what happens when AI starts doing the work regulatory professionals have always done?

Marcus and I will get into how AI is already changing regulatory work, the difference between general AI and the emerging vertical AI systems, and the scenarios that could reshape the profession, so you leave with a practical way to separate hype from reality and think clearly about your own future in RA.

🗓️ Upcoming Events & Webinars

July 10, 2026 | 11:00 AM ET — When AI Replaces Regulatory Professionals: What Happens Next?, featuring Marcus Emne (Compliance Studio). Register Now >>

🎤 In Case You Missed It

QMSR Unpacked with Michelle Lott and Dawn Balasz-Metz

June 30, 2026 | QMSR Unpacked: The New FDA Playbook for Quality System Readiness, featuring Michelle Lott, RAC, and Dawn Balazs-Metz, gave a section-by-section tour of what actually changes under the QMSR.

The big shift is that FDA can now inspect records it never could before, including management review, and it can write a 483 when a risk-based approach isn't threaded across the whole quality system.

They walked design controls, risk management, CAPA, management review and complaints, with Dawn adding the EU and ISO 13485 read on each.

Watch the replay >>

💥 Weekly 510(k) Roundup

June 29, 2026 | From Marcus Engineering, LLC

57 clearances this week, including 15 first-time clearances (🚀).

Featured first-time clearances:

🚀 Intelligent Dots, LLC — BedDot: a contact-free health monitor that slips beneath a mattress and tracks breathing, heart rate, and movement overnight without anything worn.
🚀 Phast Corp. — PhAST Blood Culture Gram-negative Panel: analyzes how individual bacteria respond to antibiotics, helping doctors identify the right treatment sooner instead of waiting a day or two for growth.
🚀 Time IS Brain, S.L. — BraiN20: a wearable brain monitoring system that continuously measures the brain's electrical activity.

Explore the update >>

📋 Regulatory Roundup

Monday, 29 June 2026 | By Martin King

Regulators moved past new legislation toward operational implementation, structured data and continuous lifecycle oversight.

FDA dominated the week with a package modernising clinical development (Master Protocols, Model-Informed Drug Development, Quantitative Systems Pharmacology, immunogenicity datasets and updated evidence standards). Australia's TGA entered the operational phase of UDI through AusUDID guidance, while the European Commission and Swissmedic pushed ahead on EUDAMED and swissdamed. EMA advanced its Network Data Strategy, Product Management Services, AI initiatives and real-world evidence programmes. ANVISA and SAHPRA expanded technovigilance and pharmacovigilance, and ENISA flagged implementation challenges for the Cyber Resilience Act. The direction across jurisdictions is a move from one-time approval to continuous, data-driven lifecycle management.