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Let's explore how ISO 13485 and MDR (EU) 2017/745 work together to streamline compliance, improve quality management, and address key challenges in the medical device supply chain. In case of doubt, just ask :)

To grab total control of your medical device's risks, look no further than ISO 14971 compliance. Kick off your project with our complete compliance checklist. #iso14971 #riskmanagement #medicaldevices https://bit.ly/3KewNOi

Are you struggling to keep up with the evolving EU MDR requirements and maintain Our FAQ on non-conformances will answer all your burning questions on the topic. 🔍What is a non-conformance and how can it be addressed through a CAPA process? 💡What methodology can be used for non-conformances and how should root cause analysis be managed? 📝Why are audits crucial for managing non-conformance reports? These questions and more will be answered in our comprehensive guide. Stay ahead of the game by understanding the importance of monitoring and addressing non-conformances in your QMS. Click the link to learn everything you need to know 👇👇 https://lnkd.in/ewS_misv At Clin-R, we believe that NCs are not failures but opportunities for continuous improvement. Let us guide you in setting up effective non-conformance procedures and processes to keep up with evolving standards and technology. #ClinR #CLINrPlus #EUmdr #nonconformances #continuousimprovement #qualitymanagement #medicaldevice #QMS #ISO13485 #ClinRFAQ #NonConformanceFAQ

Take Your Medical Device Business to the Next Level! Are you looking to enhance your quality management system and ensure compliance with international standards? Our latest white paper, "Discover the Benefits of ISO 13485 for Your Business," is here to guide you! In this guide, you’ll learn: - What is ISO 13485? - Understanding ISO 13485 - What is the legal significance of ISO 13485? - What you should consider when applying for ISO 13485 certification Download now and take the first step towards excellence in quality management: https://lnkd.in/d6fHj_v5 #ISO13485 #MedicalDevices #QualityManagement #Compliance #WhitePaper #DownloadNow Sigrid Uhlemann Szymon Kurdyn Heinrich von Mettenheim Claire Dyson Yuan Li, PhD Lisa Brandon Mahantesh Dhabe Jaques Terblanche Karin Yang

🚨 Breaking Down ISO 13485: Why It’s Crucial for Medical Device Manufacturers 🚨 Achieving certification isn't just about ticking boxes; it's about: ✅ Building trust with customers and stakeholders ✅ Expanding access to global markets like the EU, UK, and US ✅ Reducing risks through robust quality management But we get it – the process can be daunting. Complex documentation, resource allocation, and audit prep can feel overwhelming. That’s where expert support makes all the difference. 💡 At Quadra, we specialise in simplifying ISO 13485 certification for businesses of all sizes. From gap analysis to audit preparation, we’ll guide you every step of the way. 📌 Want to know more? Check out our latest blog, where we tackle: 🔍 The benefits of ISO 13485 certification 🔍 How to overcome common challenges 🔍 FAQs to help you get started 👉 Read the blog here: https://lnkd.in/eeYcJ7nP Ready to take the first step toward ISO 13485 certification? Contact us today and let’s unlock new opportunities for your business! 🚀 🌐 https://lnkd.in/d73BwRd 📧 [email protected] ☎️ +44 28 9042 3222 / +3531 832 1493 #ISO13485 #MedicalDevices #QualityManagement #Compliance #RegulatoryStandards #Quadra #QualityAssurance

🚀 Special Offer Alert: ISO 13485 Templates Bundle at QMSREGS.com! 🚀 Are you looking to streamline your medical device quality management system? QMSREGS.com has an unbeatable offer just for you! Get our full bundle of ISO 13485 templates for only £399.99, usually priced at £699.99! 🌟 Why Choose Our ISO 13485 Templates Bundle? 🌟 🔍 Comprehensive Coverage: Our templates cover all aspects of ISO 13485 requirements, ensuring you have everything you need for compliance. ✅ Simplified Compliance: Easily navigate the complexities of ISO 13485 with our expertly crafted templates, designed to make your compliance journey smooth and straightforward. 📈 Boost Efficiency: Save time and resources with pre-made templates that are easy to customize and implement, enhancing your operational efficiency. 💡 Expertly Developed: Created by industry professionals with extensive experience in ISO 13485, our templates provide you with reliable and high-quality tools. 💰 Unbeatable Value: Take advantage of this limited-time offer and get the complete bundle for only £399.99, down from the regular price of £699.99. That's over 40% in savings! Don't miss out on this incredible deal to elevate your quality management system and ensure compliance with ISO 13485. 🔗 Explore more and get your bundle today at QMSREGS.com 🔗 #ISO13485 #QualityManagement #MedicalDevices #Compliance #SpecialOffer #Templates #QMSREGS #OperationalExcellence

Ensure your medical devices remain on the market with confidence. Our latest blog provides a comprehensive guide to scoping and implementing ISO 13485. Learn how to avoid the biggest mistakes that can derail your compliance efforts and jeopardize product availability ➡  https://lnkd.in/dXHG7rDB Achieving ISO 13485 certification demonstrates a strong commitment to quality and patient safety. Although not required in the EU or the US, adhering to ISO 13485 is the most straightforward way to ensure the highest standards for your #QualityManagementSystem. Implementing an ISO 13485 quality management system is a rigorous discipline. So, what challenges must you overcome to elevate your QMS to the next level? One significant challenge is giving your #CAPA (Corrective and Preventive Actions) process the attention it deserves. When you start conducting internal audits, you may find that the CAPA section consumes most of your time. You're not alone—many manufacturers face difficulties in establishing robust and complete CAPA processes. While some struggle with building effective systems, the majority grapple with flawed investigations. From employees not fully grasping root cause analysis, to missing deadlines, to CAPAs failing to prevent future issues—we've seen it all. #ISO13485 audits often focus intensely on the CAPA process. It's crucial for your success to ensure that your CAPAs are thoroughly documented, properly researched, completed on time, and effective at preventing the recurrence of issues. But that’s just one of the major mistakes. Discover four more critical pitfalls in our latest blog! 

🌟 Elevate Your Medical Device Quality with ISO 13485:2016! 🌟 Are you in the medical device industry? Ensure your products meet the highest quality standards with ISO 13485:2016 certification. Here’s how it benefits you: ✅ Enhanced Product Quality: Implementing ISO 13485:2016 ensures your products meet global standards, increasing reliability and performance. ✅ Regulatory Compliance: Stay ahead of regulatory requirements, avoiding costly fines and ensuring patient safety. ✅ Market Access: Open doors to new markets worldwide with a certification recognized and respected globally. ✅ Risk Management: Identify and mitigate risks early, ensuring a smoother production process and fewer recalls. ✅ Customer Trust: Build and maintain customer confidence with a proven commitment to quality and safety. Get certified and take your business to the next level! 💼💡  #qaicertificationservices #ISO13485

ISO 14971 is one of the most referenced and quoted #riskanalysis guidance documents in the medical device industry. The guidance’s influence sometimes extends well beyond just #medicaldevices. In this new Med Device Online article, Mark F. Witcher, Ph.D. puts a new lens on the risk model in Annex C of ISO 14971 using relational risk analysis to describe a better approach for understanding and managing risks. https://lnkd.in/eFtP6uJV #iso14971 #riskmanagement