Alex Bourdon

Many startups treat QMS as something you install before inspection. Regulators see it as proof that your success wasn’t accidental. A QMS isn’t about paperwork — it’s about demonstrating repeatability, control, and accountability as complexity grows. This section reframes QMS as an operating backbone: 🎾 Why results without systems aren’t trusted 🎾 What “minimum viable QMS” really means for startups 🎾 How QMS supports evidence integrity and submissions 🎾 Design controls as strategic protection, not overhead 🎾 Common shortcuts that fail under audit 🎾 When to scale QMS sophistication and when not to If your QMS lives in a binder, your approval is living on borrowed time. https://lnkd.in/gHhJB5VG #RegulatoryStrategy #DiagnosticRegulation #IVDRegulatory #IntendedUse #ClaimsArchitecture #AnalyticalValidation #ClinicalValidation #IRB #IDE #FDA_PreSub #RegulatoryExecution #QMS #ChangeControl #PostMarketSurveillance #RegulatoryReadiness

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📋 Preparing for QMSR compliance doesn't have to be overwhelming. From building a solid Quality Plan to updating outdated terminology and references, every detail matters. Have you incorporated QMSR into your Quality Manual and procedures? Read our latest blog for practical steps to get it right. https://lnkd.in/gH2y9AXk Lean into quality with medical device systems everyone can trust. #QMSR #MedicalDevices #QualityManagement #ISO13485 #RegulatoryCompliance

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New Balance Expands Central Maine Facility, Boosting U.S. Manufacturing In a recent announcement on Sep 22, 2025, New Balance unveiled the expansion of its Central Maine facility, marking a significant investment of $65 million. The renowned footwear and apparel manufacturing company has added 120,000 sq ft of new space and revamped an additional 20,000 sq ft within the existing infrastructure. This strategic move not only solidifies New Balance's presence in U.S. manufacturing but also enhances its operational capacity in Maine. The expansion is set to benefit 400 employees, contributing to the growth of the workforce and reinforcing the regional supply chain network. Sources: https://lnkd.in/eDD2sB5h https://lnkd.in/erf_seNC

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The FDA’s new draft guidance clarifies which QMS details belong in PMA/HDE submissions under the QMSR (aligned with ISO 13485, effective Feb 2, 2026). In practice: Clearly show how your processes, supplier controls, software validation, and records work. This reduces questions and surprises. My tip: Schedule a quick QMSR gap check now and structure your submission accordingly. Our QMSR Gap-Assessment can help: https://lnkd.in/dRszX4AA #FDA #QMSR #medicaldevices

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Sharing a brief summary of FDA's Device Inspection Compliance Program to help understand different types of inspections that will be conducted, and what will be covered. Hoping this will be a useful resource to accompany your internal inspection prep and FDA readiness activities. Let us know what you think! If you're interested in collaborating with QualityHub on these or other projects, reach out for a conversation!

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The FDA has released it's new Risk-Based Inspection Model under QMSR allowing them to inspect other areas of documentation that were previously off limits to them. Are you ready?

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As we move into QMSR, it is imperative to recognize that your previous CAPA extension process will be judged differently. If 100% of the extensions are approved (excusing the inefficiencies of multiple revisions of the extension request documentation), your extension process ceases to have any real value, regardless of the level of management signing off.

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Today, FDA published its weekly list of recent Warning Letters. This Warning Letter to ASP Global only cited one QMS area - purchasing controls, while also citing violations related to the MDR regulation, Corrections and Removals regulation, and a failure to get clearance before marketing a significantly changed device. This one statement in sub-section C of citation 1 (Purchasing Controls) struck me as particularly interesting: "C. (b)(4) [the supplier] was audited by FDA in (b)(4) and received four observations, but ASP Global was not notified until April 29, 2025, after (b)(4) was placed on Import Alert, despite working closely with (b)(4) on SCAR-339 from February to March 2025. The ASP/(b)(4) Quality Agreement, Section 2.3, Page 6 of 15, states "(b)(4) shall notify ASP in writing within (b)(4) if any of the following occurs: (c) (b)(4) becomes aware of any inspection or audit findings that affect safety, effectiveness, conformity, or availability of product."" Effectively, ASP Global was cited in the Warning Letter because its supplier failed to notify it of the outcome of an FDA inspection (i.e., import alert) despite a requirement to provide such notification in the Supplier Quality Agreement (SQA). Initially, it seems unfair that FDA would cite a firm for something its supplier failed to do, but it speaks to a very important need within supplier quality teams at medical device manufacturers. SQAs cannot be once-and-done documents. The ongoing monitoring of suppliers (21 CFR 820.50 and ISO 13485:2016, clauses 4.1.5, 7.4.2) must include ensuring that the supplier is meeting all of its obligations under the SQA. As we see from this WL, FDA may hold you accountable for a supplier not complying with an SQA if they feel you haven't done your job in enforcing its provisions. https://lnkd.in/gsQ-cyjZ

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The FDA is hosting a free town hall on April 1 to walk through the updated inspection process under the new QMSR framework. This is the first public walkthrough of how the new process works. If you have questions for the panel, email QMSR-Rule@fda.hhs.gov. We discovered all questions must be received by March 16, 2026 to be considered for the discussion. Here's what stands out from reading the new compliance program: → Inspectors use the manufacturer's own risk management documentation to focus the inspection — and review it throughout, not just at one checkpoint → For compliance follow-ups, inspectors evaluate the timeliness and depth of corrective actions, whether corrections addressed product already in the field, whether risk management was considered, and whether the fix was scoped across the entire QMS — not just the area where the problem was found In other words: FDA is auditing your project management discipline, even if they don't call it that. Medical device timelines slip for three predictable reasons: → Unknown work stays hidden until late in the project → No single owner is accountable for surfacing uncertainty → Tasks are too big to estimate, so dates are guesses that keep moving We've published our full approach to preventing timeline slips, and encourage reading this before attending the town hall: 𝗞𝗲𝗲𝗽 𝘀𝗽𝗹𝗶𝘁𝘁𝗶𝗻𝗴 𝘁𝗮𝘀𝗸𝘀 𝘂𝗻𝘁𝗶𝗹 𝘁𝗵𝗲𝘆'𝗿𝗲 𝗲𝘀𝘁𝗶𝗺𝗮𝗯𝗹𝗲. If the owner can't answer "How long will this take?", "What is left to do?", and "What inputs do you need before you can start?" — split it further. 𝗢𝗻𝗲 𝗮𝗰𝗰𝗼𝘂𝗻𝘁𝗮𝗯𝗹𝗲 𝗼𝘄𝗻𝗲𝗿 𝗽𝗲𝗿 𝘁𝗮𝘀𝗸. Others can contribute, review, and approve — but one person drives it to completion. Without this, schedule risk stays hidden. 𝗗𝗲𝗹𝗶𝘃𝗲𝗿𝗮𝗯𝗹𝗲𝘀, 𝗻𝗼𝘁 𝗮𝗰𝘁𝗶𝘃𝗶𝘁𝗶𝗲𝘀. "Cybersecurity documentation complete" — not "Work on cybersecurity." If the goal is FDA clearance, the eSTAR deliverables are your checklist. 𝗧𝗵𝗲 𝗚𝗮𝗻𝘁𝘁 𝗰𝗵𝗮𝗿𝘁 𝗶𝘀 𝗮 𝗹𝗶𝘃𝗶𝗻𝗴 𝗺𝗼𝗱𝗲𝗹. Run weekly or biweekly reviews where each owner updates completion dates, status, and blockers. Without this cadence, the chart goes stale and loses its value as a forecasting tool. 𝗙𝗼𝗿𝗰𝗲 𝘂𝗻𝗰𝗲𝗿𝘁𝗮𝗶𝗻𝘁𝘆 𝘁𝗼 𝘁𝗵𝗲 𝘀𝘂𝗿𝗳𝗮𝗰𝗲. Once timeline risk is visible, you can optimize — add resources, reduce scope, or push work until after the first submission. This is the approach Innolitics uses when delivering 510(k) submissions on guaranteed timelines. Full article: https://hubs.li/Q046P9cy0 #FDA #QMSR #MedicalDevices #MedTech #ProjectManagement #RegulatoryAffairs #ISO13485

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🚨 Major Update from the FDA! A Must Read! The FDA has announced it will expand unannounced inspections to foreign manufacturing facilities, aligning global oversight with domestic standards. This significant shift emphasizes the importance of constant compliance readiness and closes the "advance notice" gap that many foreign manufacturers have relied on for years. 📌 Attention, manufacturers exporting to the U.S.: inspections can now happen at any time. Ask our FDA compliance experts your questions now: https://hubs.ly/Q03lJmws0 🔗 Read the full announcement: https://hubs.ly/Q03lJqhg0 #RegulatoryAffairs #FDA #Compliance #MedicalDevices #Pharma #GMP #QualityAssurance #ArazyIntelligence #ArazyGroup

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Thanks to SFMA for their continued collaboration with our Lunch N Learn program. Both our MedTech and industry attendees learned valuable insights from Dan Recuset who covered best practices and processes for CAPA. Many companies struggle with completing and thoroughly documenting their CAPA work and Dan covered some of the pitfalls as well as how to overcome them. If you have questions about CAPA or need insights into better management of your CAPA process you can reach out to us at info@bioteknica.com #BioTeknica #SFMA #CAPA

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Bezwada Biomedical is excited to present a range of functionalized amino acids and absorbable polymers designed for controlled release applications. Our portfolio features polymers derived from functionalized amino acids, which offer customizable physical and mechanical properties along with a hydrolytic degradation profile. Upon degradation, these polymers release biocompatible molecules safely. Key applications include: - Drug delivery - Tissue engineering For more details, please visit: https://lnkd.in/egPVC7gW

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