Tushar Patil

Identify and eliminate recurring errors efficiently with SECA's precise root cause analysis and get suggestive & actionable CAPAs. Simplify your investigative process and ensure consistent improvement with SECA's user-friendly interface, empowering your team to tackle issues head-on and maintain operational excellence. Streamline your error management and enhance your QMS with SECA! #innovation #technology #investigations #linkedin

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🗝OUT NOW in the JMDR May 2024 issue: 🗝US FDA finalises rule incorporating ISO 13485 into new Quality Management System Regulation (QMSR) Are you aware of the revisions in the FDA’s Quality System requirements for medical devices? This new article from GlobalRegulatoryPress.com will help you understand: 🗝the content of the QMSR 🗝key differences between the QSR and QMSR 🗝and steps that manufacturers should take to prepare for implementation of the QMSR. by Pamela Forrest and Amy Leiser https://lnkd.in/dKNMZZNy #regulatoryaffairs #medicaldevices #samd #medizinprodukte #dispositivimedici #dispositifsmedicaux #dispositivosmedicos

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The #1 issue FDA finds with CAPA procedures. In 2023, FDA issued 252 inspection observations related to establishing procedures for corrective and preventive action. 🚨 This was the most common finding, just like it is every year. Let's break it down a bit more. Of all the requirements in 820.100, two main things showed up the most in warning letters last year. One of those is analyzing sources of quality data to identify quality problems. So, how can you make sure this doesn't happen to you? During your planning, you should do the following: 🔍 Identify important sources of data (complaints, suppliers, service, etc.). 🔧 Provide enough resources, including personnel, infrastructure, or training. 🧑‍💼 Set up clear roles and responsibilities for those people. ✅ Define what's needed for each data source, including limits, acceptance criteria, escalation criteria, and ways to report issues. 📈 Analyze the data from these sources. By doing this, you can make sure your quality processes connect to measurement/analysis/improvement, and avoid getting an observation of your own! (I'll touch on the second biggest CAPA procedure FDA finds in another post!) P.S. If you liked this post you'll enjoy my newsletter. Every week I share tips and insights for getting your QMS ready for FDA and notified bodies. Join hundreds of subscribers here: https://QARAsolutions.com/

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Failure Mode Effects Analysis (FMEA) vs. ISO 14971 Risk Management... are you clear on the differences between them? 🤔 While FMEA can and should be used as a helpful tool for design and development teams evaluating materials, components, and sub assemblies comprising medical devices, it is NOT a substitute for the Risk Management standard. FMEA is different in both its scope and purpose. The basis of FMEA is identifying failure modes. However, the risks inherent in medical devices are not solely a function of failure. A medical device might never exhibit a failure mode, yet it may still have risks. We go more in-depth on these distinctions in this article: https://hubs.ly/Q02ZtQ5_0. #FMEA #iso14971 #riskmanagement #medicaldevices #medtech #regulatorycompliance #greenlightguru #premarket

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Here’s why you're getting low-value audit findings. Too much time is spent debating minor issues. Not enough time reviewing what really matters. But here's the thing: If you put it in your QMS, it's fair game for an audit. If it doesn’t help quality, compliance, or make your team more effective, then it doesn’t belong there. If you keep it simple, you can focus on:     CAPA processes that actually improve quality.     Clear adverse event reporting criteria.     Robust supplier controls. P.S. what's the most ridiculous audit finding you've received? I want to hear about it! 👇

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Companies often struggle to upgrade QMS and seek modern technologies to accurately identify root causes and implement effective CAPAs. SECA offers intelligent tools and techniques that efficiently help organizations overcome these persistent challenges. If you're experiencing similar issues, book a demo today! #innovation #technology #investigations #linkedin

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Hey everyone, Darren Reeves here with another DP Minute! Today, we’re diving into the QMSR Preamble Comment #40.The comment suggested that the QMSR should include a definition of "critical supplier" as defined in MDSAP. Watch the video to see how the FDA responded, and to understand the expectations in the QMSR of medical device manufacturers related to supplier evaluation and identifying who their critical suppliers are (including consultants). Our DP Minutes are created to help you navigate the nuances of medical device regulations. Have questions or want to dive deeper? Visit DPDConline.com for more insights and connect with us on LinkedIn to join the conversation. #QMSR #ISO13485 #FDA #MedicalDevices #DPDConsulting #MedicalDeviceRegulatoryConsulting #SupplierEvaluation #MedicalDeviceManufacturing #DPDC #MedicalDeviceConsultation

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Medical device manufacturers this is for you. Watch the video to see how the FDA responded, and to understand the expectations in the QMSR of medical device manufacturers related to supplier evaluation and identifying who their critical suppliers are (including consultants). #medicaldevice #medicaldevicedmanufacturer #criticalsupply #FDA

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Hello everyone, Darren Reeves here from DP Distribution & Consulting, LLC®, bringing you another insightful DP Minute. Today, we’re diving into Comment No. 23 from the QMSR discussions. This particular comment raises important questions about how manufacturers should align their existing quality management systems with the new QMSR standards. The FDA's response highlights the unique nature of each organization’s QMS, and declines to offer any advice.  However, Darren outlines an efficient and wise way to approach the transition. Watch this video to hear some great advice on how your organization can maneuver the time between now and when the QMSR is in effect. If you're navigating these regulatory changes, you're not alone. For more detailed insights and to discuss your specific needs, visit us at dpdconline.com or connect with us right here on LinkedIn. Let’s tackle these regulatory challenges together! #QMSR #ISO13485 #FDA #MedicalDevices #DPDConsulting #RegulatoryCompliance #QualityManagementSystem #MedicalDeviceConsultation

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Hey everyone, Darren Reeves here with another important DP Minute! Today, we’re diving into Comment #79 from the QMSR Preamble discussions. This one touches on a big question in the industry: will the FDA accept ISO 13485:2016 certification from MDSAP as a substitute for FDA inspection? The FDA’s response? Watch the full video for all the details and visit DPDConline.com to dive deeper. Have questions or thoughts? Connect with us here on LinkedIn and join the conversation! #QMSR #ISO13485 #FDA #MDSAP #MedicalDevices #DPDConsulting #MedicalDeviceRegulatoryCompliance #MedicalDeviceConsultation #DPMinutes #DPDC

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MDCG 2021-25 Rev.1 Guidance Document This document outlines the application of MDR requirements to legacy devices and those placed on the market before May 26, 2021. It provides clarity on how manufacturers should comply with the updated regulations for these devices, ensuring ongoing safety and performance in the market. This guidance is essential for anyone involved in managing legacy devices within the medical device landscape. #MDCG #MDR #MedicalDevice #LegacyDevices #MedicalConsulting

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Building a medical device is not easy. Aside from navigating the complex medical device regulatory environment, there are lots of intricate features & channels, and functionalized chemistry to consider/integrate. Fortunately, our team can help.🤝 Using our toolkit of modern fabrication technologies, we deliver: ✅ Precision lamination of multiple material layers ✅ Micron-level features (reagent reservoirs, fluidic channels, etc) with #laser View our full toolkit of technologies in the comments below.👇🏻 #medicaldevicemanufacturing #biotechnology #labonachip #pointofcare

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Quality matters, especially in medical manufacturing. If you’re choosing a partner to start producing your device, here are two key questions to ask: ➡️What’s in their QC plan? A good plan has layered checks—early audits, in-process inspections, and final reviews. ➡️Can they tailor quality controls to your project? Look for a team that customizes QC for your unique needs, from assembly to packaging. To celebrate World Quality Day, check out our guide on key questions to ask: https://lnkd.in/eKW3WvN5 #WorldQualityDay #Quality #QualityManufacturing #MedicalManufacturing #QCPlan #Inspection

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The FDA announced its final rule on lab-developed tests (LDTs). How will it transform the landscape of diagnostic testing and innovation? Will it slow progress? Will companies commit the time it takes to bring products through the full process? All important questions! We wrote about the ruling details, phased approach to implementation, and diverse reactions from various industry experts on our blog: https://ow.ly/sYOY50Ru1Sc

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𝑫𝒊𝒅 𝒚𝒐𝒖 𝒌𝒏𝒐𝒘 𝒕𝒉𝒂𝒕 𝑭𝑫𝑨 𝒅𝒊𝒅𝒏'𝒕 𝒅𝒆𝒇𝒊𝒏𝒆 "𝒃𝒂𝒕𝒄𝒉" 𝒐𝒓 "𝒍𝒐𝒕" 𝒊𝒏 𝒕𝒉𝒆 𝑸𝑴𝑺𝑹 𝒇𝒊𝒏𝒂𝒍 𝒓𝒖𝒍𝒆? The FDA's finalized Quality Management System Regulation (QMSR) has been harmonized with ISO 13485:2016 to streamline regulatory compliance for medical device manufacturers. However, it is important to note that the QMSR does not explicitly define the terms ✅ "batch" or ✅ "lot" within its framework. Manufacturers should continue to refer to existing internal definitions or other applicable FDA guidance and industry standards for these terms to ensure consistency in production and quality control documentation. FDA says they would include a definition in comment 29. Did you already started to implement QMSR in your company ❓

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