AI Governance Comes of Age in MedTech

MedTech Leading Voice | Issue 163

📝 From the Editor

Just back from RAPS EuroConvergence in Lisbon — strong conversations across devices, IVDs, and digital health, with practical exchanges on EU regulatory implementation, post-market expectations, and how teams are adapting to lifecycle-based oversight. I shared a couple of recaps on LinkedIn last week capturing what stood out.

A quick note:voting for the MLV100 closes May 30. Nearly 3,200 votes and nominations have been submitted so far. If you haven't yet, take a moment to weigh in at mlvx.ai/mlv100.

And on a personal note — I turn 60 today, sharing the day with Mother's Day (and with my own mother, buon anima, in spirit). Thank you to everyone who has been part of the journey. Here's to the next chapter.

— Sean Smith

🧠 Featured Post

Independent Control and Governed Output — Martin King on AI Systems in Regulated Environments

Martin King outlined the importance of independent control and governed output in AI systems in his latest article, framing these as foundational requirements as AI moves deeper into regulated workflows.

The piece sits alongside a broader trend visible across this month's regulatory activity: AI oversight is shifting from principle to expectation. IMDRF, MHRA, FDA, and ENISA have all published new AI governance, SBOM, and cybersecurity frameworks, and lifecycle controls are becoming central to how AI-enabled products are evaluated and maintained.

For MedTech teams building or integrating AI, these expectations now influence development, validation, post-market, and quality system decisions. View the post >>

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

• Martin King discussed the importance of independent control and governed output in AI systems from his latest article.
• A guide on Perplexity vs. Claude and when to use each across regulatory workflows, outlined by Benjamin Arazy.
• Phil Englert highlighted cybersecurity risks in medical devices and their impact on modern device ecosystems.
• Risk management as a continuous, lifecycle driven process in medical devices, spanning hazard identification, control, and post market feedback, outlined by Asiya Habeeb.
• Saidatul Huda shared Thailand's medical device regulatory framework across the product lifecycle.
• The role of structured problem statements in strengthening CAPA investigations and reducing downstream issues, overviewed by Georg Digel.
• Marina Daineko explained the transition from legacy QSR terminology to QMSR-aligned documentation and its impact on submission consistency.
• Common pitfalls in applying IEC 62304 safety classifications and overreliance on procedural controls in higher-risk scenarios, revealed by Christian Rosenzweig.
• Trends in FDA AI-enabled medical devices including rapid growth and radiology dominance, analyzed by Ramin Parchetalab.
• Etienne Dejoie underscored key challenges in AI adoption for QARA teams from a recent interview.
• Hidden reasons for the failure of medical devices at later stages, discussed in the latest newsletter by Renuka Dixit.

🎯 Featured Event

In Silico Evidence and the Future of Clinical Evaluation

June 12, 2026 | 11:00 AM ET

In silico evidence is becoming a practical consideration for medical device developers, clinicians, notified bodies, regulators, investors, and MedTech consultants.

This Friday in Focus session features Surash Surash, Clinical Reviewer at TÜV SÜD, joining the MedTech Leading Voice community for a clinical and regulatory discussion on how in silico methods can support safer, faster, and more intelligent medical device development. Surash brings a rare combination of perspectives: former neurosurgeon, regulatory affairs expert, medical law background, and active involvement in conversations around orphan devices, clinical evidence, and in silico methodologies.

The session will explore:

• How in silico evidence can support clinical evaluation and device development
• Why simulation may be especially relevant in high-risk areas such as cardiac and neuro devices
• How modeling can reduce patient exposure while supporting stronger evidence generation
• The role of in silico methods across the full device lifecycle, including post-market surveillance and PMCF
• What consultants, manufacturers, clinicians, and regulatory professionals should understand as the field evolves
• How new regulatory and standards activity may shape adoption in the coming years

Register Now >>

🗓️ Upcoming Events & Webinars

• Thurs, May 14, 2026 | 10:00 AM ET — Beyond Human Factors: Identifying the Barriers to Real-World Use. Featuring Alper Hulusi, Head of Market Insights at ClariMed.
• Fri, May 15, 2026 | 11:00 AM ET — The QMS conversation your clients are having without you: From compliance advisor to embedded QMS partner in 90 days. Featuring Charles Rollet, CEO of TraceX.
• June 12, 2026 | 11:00 AM ET — In Silico Evidence and the Future of Clinical Evaluation, featuring Surash Surash, Clinical Reviewer at TÜV SÜD.

💥 Weekly 510(k) Roundup

May 4, 2026 | From Marcus Engineering, LLC

60 total clearances this week across multiple categories, with 12 first-time clearances (🚀).

Featured clearances:

• 🚀 Bayesian Health – Sepsis Flagging Device (K250680): An algorithm built into hospital systems, acting as an early warning for one of the hardest conditions to catch. Continuously analyzes patient data like vitals and lab results to connect signals earlier so care teams can step in when it matters most.
• 🚀 LifeScience Plus – BloodSTOP iX Trauma Matrix (K253017): Built for emergency scenes, from ambulances to field care. A flexible, gauze-like dressing placed directly on the wound, activated by the blood itself, forming a gel barrier to help stop heavy bleeding quickly when every second counts.
• 🚀 ANEUVO – ExaStim: Built for spinal cord injury rehab, using flexible electrode pads on the skin to stimulate the spine during guided therapy. Designed for patients with incomplete injuries, it adds non-invasive stimulation to movement exercises, both in the clinic and at home.

Full breakdown available in the May 4, 510(k) Roundup >>

📋 Regulatory Roundup

May 4, 2026 | By Martin King

"Pilot" is everywhere. Across global regulators — from the EMA's breakthrough device pilot, to the FDA's AI clinical trial programme, to Swissmedic's FAST-Track pathway — regulators are testing the future, shaping policy through real-world implementation, and moving toward faster, data-driven, and more collaborative regulation.

At the same time, the system is tightening. Stronger Notified Body oversight under TEAM-NB, higher expectations for technical documentation, and a clear shift toward "right-first-time" submissions are raising the bar for manufacturers.

The result is a regulatory landscape moving in two directions at once: acceleration of innovation pathways alongside intensification of scrutiny and control.

Explore the update >>

🔥 Postscript

MLV100 — Voting Closes Soon!

Nearly 3,200 votes and nominations have been submitted for the MLV100. Cast your vote at mlvx.ai/mlv100 before voting closes.

Sean 🐝