SaMD Software Updates: Bug Fixes vs Significant Changes

MedTech Leading Voice | Issue 165

📝 From the Editor

Final week to vote. MLV100 2026 nominations and voting close May 30. If you haven't cast your vote yet — or there's someone we missed — now's the time: mlvx.ai/mlv100.

Thanks to Simon Föger, CEO & Founder of SIFo Medical, for last Friday's MLVx Friday In Focus session on the 7 Deadly Sins of Test Method Validation. Watch the Replay >>

Looking ahead, this Thursday's webinar with Michelle Lott and Tianna Benson of leanRAQA walks through what FDA expects after a Form 483. Register now >>

— Sean Smith

🧠 Featured Post

SaMD Software Updates — Bug Fixes vs Significant Changes

Dr. C. Sheela Sasikumar contrasted the difference between bug fixes and significant changes in SaMD software updates and their regulatory impact.

The distinction shapes how teams document, validate, and notify regulators across the device lifecycle — and where pre-determined change control plans, version control discipline, and post-market reporting obligations come into play. View the post >>

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

• Stefano Bolletta highlighted upcoming IVDR deadlines and compliance requirements for IVDD self-declared Class C device manufacturers.
• Draft EU guidelines on classifying high-risk AI systems and the role of intended use in risk designation, announced by Danny Van Roijen.
• New EU guidelines on responsible Generative AI use in research and impacts across R&D, QA/RA, and compliance, shared by Barbara Pirola.
• BSI Medical Devices noted the publication of the EU 2026/977 regulation on Annex VII revisions and ongoing implementation efforts.
• An article on stricter medical device regulation and evolving safety standards was written by Bethany Dean.
• Sharath Chandra Bhat examined PFAS-free medical device innovation and the challenge of balancing material performance, safety, and regulatory compliance.
• A regulatory walkthrough of a real cardiac monitoring app and its compliance considerations was underscored by Oruc Kahriman.
• Network Partners Group underlined proposed MDR and IVDR revisions aimed at reducing regulatory burden and supporting MedTech innovation.
• New FDA CDRH Learn modules on real-world evidence, patient preference information, and updated regulatory pathways were summarized by Martin King.
• Helen Peter posted on CE marking fundamentals under EU MDR and IVDR, covering risk classification and certification requirements.
• Updates to the EUDAMED UDI Devices user guide and EU medical device registration requirements were revealed by Stefano Bolletta.
• Recurring blind spots in IEC 60601-1 compliance and medical electrical equipment development were discussed by Beat Keller.

🎯 In Case You Missed It

The 7 Deadly Sins of Test Method Validation with Simon Föger

Last Friday's MLVx Friday In Focus session with Simon Föger,CEO and founder of SIFo Medical, walked through the seven most common test method validation failures behind FDA warning letters: assumption, hindsight, illusion, arbitrariness, subjectivity, idealism, and stasis.

Föger noted that 25–30% of FDA warning letters relate in some way to test method validation.

Across the seven sins, his core message was consistent: "Validate the system, not just the box." Calibration is not validation. Acceptance criteria must be defined before the formal run. Statistical choices — gauge R&R thresholds, sample sizes, confidence and reliability levels — must be tied back to risk management. Visual inspections require qualifying both the environment and the operator, including visual acuity.

His three closing principles: build a culture of statistical rigor, validate the system rather than just the equipment, and treat TMV as a lifecycle activity that has to be reassessed after changes.

Watch the replay >> | Downoad Slides >>

🎯 Featured Webinar

From Observation to Action: What FDA Expects After a 483

Join us this Thursday, May 28 at 12:00 PM ET

An FDA Form 483 gives your team a short window to show that you understand the observations, have contained the immediate risk, and are building a credible path to correction.

In this practical webinar, Michelle Lott, RAC, Principal and Founder of leanRAQA, and Tianna Benson, Senior Regulatory and Quality Manager at leanRAQA, will walk MedTech teams through how to respond to an FDA 483 with clarity, structure, and confidence.

They'll explain what a 483 really means, how it differs from a Warning Letter, and why the quality of your 15-business-day response can influence what happens next. The session will cover how to restate the observation, identify what requirement was missed, document containment, investigate root cause, assess systemic impact, and build a corrective action plan FDA can follow. Register Now >>

🗓️ Upcoming Events & Webinars

• May 28, 2026 | 12:00 Noon ET — From Observation to Action: What FDA Expects After a 483, featuring Michelle Lott and Tianna Benson from leanRAQA.
• 🔥 NEW: May 29, 2026 | 11:00 am ET — What ChatGPT Doesn't Know About Sterilization, featuring Manuel Grandy of SteriComp.
• June 1, 2026 | Boxborough, MA (and Virtual) — IEC 60601-1 4th Edition Seminar,an Overview and Q&A with Members of the Standards Team. Free in-person/virtual seminar hosted by Leo Eisner and TÜV Rheinland.
• June 2–5, 2026 | Boston — IMSC26 International MedTech Safety Conference. Use MLV codes to register: MLV$200 (general, in-person or virtual), Start$250 (startup in-person), StartEd$50 (startup education day).
• 🔥 NEW: June 5, 2026 | 11:00 am ET — Why MDR Technical Files Keep Breaking Down, featuring Nicolas Gehring and Leon Kobinger of CertHub.
• 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 18, 2026 | From Marcus Engineering, LLC

67 total clearances this week across multiple categories, including 11 first-time clearances (🚀).

Featured clearances:

• Elucent Medical Inc. — SmartClip Delivery Catheter: Places a tiny wireless locator into suspicious breast tissue that may later need to be removed during surgery, replacing traditional wire localization with real-time navigation in the operating room.
• 🚀 Surgimage Corporation — SIM 1000H Fluorescence Imaging Platform: Helps surgeons see anatomy, blood flow, and structures that are difficult to spot under normal operating room lighting, after a fluorescent dye is introduced into the body.
• 🚀 Alife Health — Embryo Predict: AI-powered tool that analyzes imaging and clinical data to help fertility specialists identify embryos with the strongest chance of successful implantation during IVF.

Full breakdown available in the May 18, 510(k) Roundup >>

📋 Regulatory Roundup

May 18, 2026 | By Martin King

The latest regulatory developments across MedTech, IVDs, pharmaceuticals, and advanced therapies show continued acceleration toward global convergence, digitalisation, and lifecycle oversight. Updates came from the European Commission, EMA, EDQM, Swissmedic, FDA, TGA, HSA, NMPA, and MHRA.

Key threads: AI regulation as a central cross-jurisdictional theme, regulatory interoperability as a strategic market-access driver, digital submissions and structured data becoming mandatory, lifecycle vigilance and post-market analytics expanding globally, and technical documentation quality remaining a major enforcement focus. Explore the update >>

🔥 Postscript

MLV100 2026 — Voting Closes May 30

This is the final week to cast your vote for the 100 MedTech Leading Voices worth following in 2026, and to nominate anyone we missed. Your vote helps elevate the people who move our field forward. Cast your vote now >>

Sean 🐝