ISO 13485 and the Future of Audit Readiness

MedTech Leading Voice | Issue 181

📝 From the Editor

Georg Digel set out this week how an ISO 13485 audit and an FDA inspection differ, and what each one is actually looking at.

🔥 Two other posts sit alongside it on what the standards require of a quality system, with over 100 ISO 13485 documentation requirements compiled in one place, and ISO 27001 and its role in information security. Martin King's roundup points the same way, that regulatory excellence now depends on implementation readiness.

— Sean Smith

🧠 Featured Post

What an ISO 13485 audit checks, and what an FDA inspection checks

Georg Digel laid out for MedTech teams how ISO 13485 audits and FDA inspections differ. The two look at the same quality system and ask different questions of it, which is why a team that prepares for one the way it prepares for the other ends up answering the wrong ones.

Two other posts this week fill in what sits underneath both. Darrin Carlson compiled over 100 ISO 13485 documentation requirements in one place. Tibor Zechmeister broke down ISO 27001 and its role in strengthening information security for MedTech organizations. For teams facing an audit or an inspection this quarter, that is the reading list.

View the post >>

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

• Tibor Zechmeister broke down ISO 27001 and its role in strengthening information security for MedTech organizations.
• Emerging AI/ML standards and their implications for medical devices were mapped out by Leon Doorn.
• EU MDR Compliance clarified the framework for defining intended use for medical device software.
• A risk-based approach to evaluating and controlling generative AI use cases in quality systems, detailed by Garth Conrad.
• Georg Digel contrasted ISO 13485 audits and FDA inspections for MedTech teams.
• In her weekly Monday News, Marina Daineko summarized updates on EMA's data submission pilot, FDA device guidance, PFAS, and digitally derived measures.
• Updated FDA dental device guidance and claim-driven evidence requirements were highlighted by Yu Zhao.
• Vanessa Yeung explored patent term extensions and broader IP strategies for medical device companies.
• FDA's request for feedback on regulating generative AI-enabled medical devices, announced by Danielle Bitterman.
• Stephanie Grassmann underscored inconsistencies surrounding WET criteria under the EU medical device framework.
• Over 100 ISO 13485 documentation requirements were compiled by Darrin Carlson.
• Raju K. Mishra covered recent FDA developments across digital health, device guidance, and post-market actions.
• Recommendations for the future regulation of AI in healthcare were overviewed by Danny Van Roijen.

🎯 Featured Launch Event

Friday, September 18, 2026, 11:00 AM ET / 8:00 AM PT — Mind the Gap: The Biggest Threat in MedTech Cybersecurity That No One Is Talking About

A medical device manufacturer publishes a security advisory and isn't sure whether it reached anyone. The contact on file changed jobs two years ago, the distribution list has not been refreshed since, and nothing comes back to confirm the message arrived. Hospitals have filled that gap by paying outside firms to scan equipment they already bought, and those scans send findings back that the manufacturer assessed and closed months ago.

On Friday 18 September, Michelle Jump, CEO of MedSec, puts that conversation in public with Matt Hazelett, MedSec's COO and Chief Quality Officer, who spent eight years at FDA leading the Section 524B implementation, and Debra Bruemmer, MedSec's Senior Director of Clinical Security, who spent 24 years inside Mayo Clinic's information security office. She is also showing BRIDGE, the platform she built about it, publicly for the first time. Sixty minutes live with a protected Q&A, free to attend, and the recording and slides go to everyone who registers whether they make it or not.

Register free >>

🗓️ Upcoming Events & Webinars

September 22, 2026 | 11:00 AM to 12:30 PM ET — FDA Ground Truth 2026, featuring Steve Silverman (President, The Silverman Group), Philip Desjardins (Partner, Arnold & Porter), David Filmore (Executive Editor, Market Pathways), Jeff Lipps (Regulatory Affairs and Quality Assurance Consultant), Angelina Lisandrelli (Director of Global Regulatory, Intuitive) and Michelle Lott, RAC (Principal and Founder, leanRAQA). Register Now >>

September 30, 2026 | 12:00 PM ET — Device Innovation to Commercialization, Phase 1: Concept. Seven Questions Before You Build a Medical Device, featuring Michelle Lott, RAC (Principal and Founder, leanRAQA) and Renae Franz (Commercialization Strategist, leanRAQA). Register Now >>

October 2, 2026 | 11:00 AM ET — Compliant, and Still Wrong: The Human Side of Risk Decisions, a Friday In-Focus session featuring Steve Gompertz (Partner, Operations and Resourcing, QRx Partners) and Jean Blom (Quality Manager, Medical Devices, Medace BV). Register Now >>

🎟️ Upcoming Conferences

• September 15–17 | Charlotte, NC — RAPS Convergence 2026 at the Charlotte Convention Center, with preconference workshops September 14–15. RAPS marks its 50th anniversary this year. Register Now >>
• 🔥 NEW: October 26–27 | Munich, Germany — The European Conference on Digital Transformation & Data in Medical Technologies (DTD2026), chaired by Clara Pessy of Platomics. Two days of keynotes, panels and industry symposia on AI-enabled medical devices, SaMD, regulatory innovation and clinical evidence generation, with Martin King among the speakers. MLV readers get 20% off registration with the code MEDTECH20. Register Now >>
• October 29–30 | Prague, Czech Republic — TEAM-PRRC Annual Summit 2026, fifth edition, at the Hilton Old Town. The European meeting for Persons Responsible for Regulatory Compliance and regulatory affairs professionals in medical devices. Register Now >>
• November 3–5 | San Diego, CA — MedTech Strategist Innovation Summit San Diego 2026 at The US Grant Hotel. A medical device partnering and investment conference. Attendee registration covers all sessions, meals, networking, and the JuJama partnering app. Register Now >>
• November 10–11 | Philadelphia, PA — PhMTI 2026 Fall Seminar: Human + Machine, The Enduring Value of Information Professionals in the Age of AI, at the Sofitel Philadelphia at Rittenhouse Square. Member rate $200. Register Now >>

💥 Weekly 510(k) Roundup

September 8, 2026 | From Marcus Engineering, LLC

59 clearances this week, including 22 first-time clearances (🚀).

Featured clearances:

• 🚀 Marani Health— M•care System: lets pregnant women do part of their prenatal monitoring from home, sending readings from a connected scale, a blood pressure cuff or a blood sugar test straight to the care team. Doctors get a chance to spot changes like rising blood pressure sooner, and women skip some of the driving, parking and time off that come with frequent office visits.
• Monteris Medical— NeuroBlate System: a robotic, MRI-guided laser system used on certain brain tumors, radiation-damaged tissue, and areas linked to epilepsy. A thin probe goes through a small opening in the skull to the target and heats that tissue while the MRI gives the surgeon live images and shows where the heat is going. That helps most when the target is deep in the brain or hard to reach.
• Boston Scientific— Rezūm System: treats an enlarged prostate using steam. The device is inserted through the urinary passage and delivers small bursts of steam to the tissue pressing on it, the body gradually absorbs that tissue, and the passage opens back up. For many men that means no cutting and no daily medication.

Explore the update >>

📋 Regulatory Roundup

September 7, 2026 | By Martin King

Martin King reads this week as digital regulatory operations, stronger PV accountability, higher IVD evidence expectations and tighter lifecycle discipline moving into day-to-day compliance.

What should be on your radar:

• EMA — IRIS is mandatory from 1 September for EMA-led PLM procedures, with specified exceptions.
• Swissmedic — new RPV requirements are in effect, covering the RPV and deputy, continuous PV coverage, local PV QMS and outsourcing oversight.
• South African Health Products Regulatory Authority — Registry and Application ID linkage and mandatory IDMP data are due by 31 October 2026. eCTD Take-On follows for active non-eCTD dossiers by 31 December 2027.
• Health Canada — generic-drug NOD/NON responses are limited to one extension of up to 90 days, and medical-device exceptional importation requirements have tightened.
• Egyptian Drug Authority — draft guidance proposes mandatory eCTD, with a new Egyptian Module 1 and structured lifecycle requirements.
• Therapeutic Goods Administration — updated COVID-19 and influenza RAT guidance reinforces expectations for clinical performance, analytical evidence, usability and risk management.
• MedTech Europe — EU MDR/IVDR transition and EUDAMED implementation continue to create downstream registration and supply implications, particularly across the Middle East and Africa.

Innovation is not slowing. EMA is advancing agile scientific advice, MIDD and regulatory sandbox initiatives, and FDA reports 1,320 Breakthrough Device designations and 210 marketing authorisations through June 2026.

Explore the update >>

🎤 In Case You Missed It

Last Friday, Michelle Lott and Tianna Benson of leanRAQA ran The Business Case for Quality: What a Culture of Quality Really Looks Like Under QMSR. More than 350 people registered. Tianna's soapbox moment was about why quality teams keep losing arguments with management:

"You need to drive the value of quality as a value creator, not the cost center. At the end of the day, they see dollar bills."

As she said, if quality changes your NC process and the count drops from 35 a quarter to 12, and each NC burns 40 hours across departments, that is a number a CFO will actually read. Same with scrap, rework, redesigns, debugging software errors, complaints, warranty, recalls. All of it is quantifiable in man-hours. The recording and slides are going to registrants. Michelle and Tianna offered an encore for the second half of the deck, which we never got to. Say the word, and I'll book it.

🔥 Postscript

I am in Charlotte, North Carolina this week for RAPS Convergence, and we are reporting live from the floor all week. Look for updates from North Carolina starting Tuesday.

Book a meeting with me >> sean@virtub2b.com

Sean 🐝