About
Over 20 years experience in the manufacturing business. Familiarity with many types of…
Articles by Scott
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The 7 Wastes
The 7 Wastes
It is difficult sometimes to appreciate how powerful the act of eliminating waste from a process contributes to the…
Activity
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On behalf of University of South Carolina Upstate we extend our congratulations to the South Carolina Gamecocks women’s basketball on an incredible…
On behalf of University of South Carolina Upstate we extend our congratulations to the South Carolina Gamecocks women’s basketball on an incredible…
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World Health Day is a reminder of why we do this work. In my role, health isn’t abstract. It is personal. It’s the patient waiting for an answer…
World Health Day is a reminder of why we do this work. In my role, health isn’t abstract. It is personal. It’s the patient waiting for an answer…
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Did you know that almost every Painted Tree location has a water feature? It’s a subtle but meaningful part of how we create environments that feel…
Did you know that almost every Painted Tree location has a water feature? It’s a subtle but meaningful part of how we create environments that feel…
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Join now to viewMore activity by Scott
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Manual audits cost more than you think. Let's do the math: Two auditors. One supplier. Three days. + Prep time + Report writing + Travel =…
Manual audits cost more than you think. Let's do the math: Two auditors. One supplier. Three days. + Prep time + Report writing + Travel =…
Liked by Scott Baker
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Being nominated for the Elevate program was such a privilege. It pushed me to think bigger, lead with greater intention, and show up differently for…
Being nominated for the Elevate program was such a privilege. It pushed me to think bigger, lead with greater intention, and show up differently for…
Liked by Scott Baker
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Stop doing a "Find and Replace" on your Quality Manual. The shift to QMSR is here. And I see a lot of companies making a dangerous mistake. They…
Stop doing a "Find and Replace" on your Quality Manual. The shift to QMSR is here. And I see a lot of companies making a dangerous mistake. They…
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Honored to be selected for Elevate, a nomination-only program for high-potential managers. This experience truly reflected what it means to Care…
Honored to be selected for Elevate, a nomination-only program for high-potential managers. This experience truly reflected what it means to Care…
Shared by Scott Baker
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The "Friday vs. Monday" Audit. We've all heard the horror stories. A Notified Body leaves on Friday saying "everything looks great." The FDA…
The "Friday vs. Monday" Audit. We've all heard the horror stories. A Notified Body leaves on Friday saying "everything looks great." The FDA…
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I've been in medical device quality for over 20 years. The audit is broken. When your audit result depends on who shows up that day, you don't have…
I've been in medical device quality for over 20 years. The audit is broken. When your audit result depends on who shows up that day, you don't have…
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I didn’t grow up an athlete. I grew into one. 🎾 This weekend, in my mid-forties, I became a state champion. When I picked up a tennis racket for…
I didn’t grow up an athlete. I grew into one. 🎾 This weekend, in my mid-forties, I became a state champion. When I picked up a tennis racket for…
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#InCaseYouMissedIt, our CEO, Monica Burt, sat down with the MedTech Digest to share why most companies are doing quality all wrong, and how to fix it…
#InCaseYouMissedIt, our CEO, Monica Burt, sat down with the MedTech Digest to share why most companies are doing quality all wrong, and how to fix it…
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Briefcases are packed. Lunches are labeled. Badges are ready. Medtronic’s back-to-school season looks a little different this year: 4 days a week in…
Briefcases are packed. Lunches are labeled. Badges are ready. Medtronic’s back-to-school season looks a little different this year: 4 days a week in…
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Pawan Kumar Sharma
The CDSCO's initiative to streamline loan license requirements for sterilization services is a welcome relief for medical device manufacturers. Once these new amendments take effect, a loan license will no longer be required for sterilizations. 👏#MedicalDevices #HealthcareInnovation #TechInHealthcare #ProfessionalGrowth #linkedin
3 Comments -
Jacob Foster, MBA
In the effort to follow the letter of the regulations, I have witnessed many organizations holding the required management reviews to "evaluate the suitability, adequacy, and effectiveness of a Quality Management System". However, the "compliance only" mindset is focused on evaluating the ability of the QMS "to function as a QMS", a siloed activity that is not operationally connected to affect the quality, safety, and performance of the manufactured products that the quality processes are intended to support.
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Andrés Gola Isasi
We need to be careful how easily our manufacturing facilities can get infected with deviations… Especially when the root cause is (allegedly) 👉 human error. 💥 If we don’t dig deeper — 🕵️♀️ beyond the surface — we risk missing the real causes: ⚙️ Poor procedures 📉 Inadequate training 🛠️ Weak systems ⏱️ Unrealistic expectations And then what? 📄💦 We drown in a flood of deviation reports… again and again. Let’s stop blaming people, and start fixing problems. 🔍 Human error is a clue — not a conclusion. #GMP ✅ #HumanError 🤯 #DeviationManagement 🧾 #Pharma 💊 #QualityCulture 🌟 #RootCauseAnalysis 🧠 #FDA #RegulatoryAffairs #Compliance #GMP #FDAInspection #QualityAssurance #PharmaceuticalIndustry #medicaldevices #biotech
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Michael Galliker
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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Chris Whelan
If you needed any more convincing that FMEA is not risk management, look no further than FDA's Compliance Inspection Manual published 30-Jan-26. Risk is not just about failure modes. Risk is about anything that can go wrong, even when everything is working as intended. Risk assessment, evaluation and control must include use and user-related risks, design, process, supply chain, biological, clinical, environmental and more AND throughout the entire product life-cycle, not just pre-market. Manufacturers who've had a US-only focus must have this in their risk management system already because the transition period is over and FDA is not waiting for you! https://lnkd.in/gQr5gRgX
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