QUAREGIA GmbH - Quality & Regulatory Compliance

Are you a medical device, in vitro diagnostic device, or medical device software company in the process of establishing a compliant QMS and a sound regulatory strategy? We provide: 👉 Expert advice to avoid QMS implementation pitfalls 👉 Customer-specific lean solutions to fulfill regulatory requirements 👉 Individual pragmatic approaches to your inquiries based on well-established QMS frameworks, as opposed to an out-of-the-box one-size-fits-all solution 👉 More information here: https://lnkd.in/eTRUB6Pk 👉 Book a 30-min FREE CONSULTATION here: https://lnkd.in/eSQHGU5m #qms #solutions #solutionsarchitect #regulatorycompliance #regulatorysubmissions #regulatorysupport #iso13485 #fda #21cfrpart802

🎉 Exciting News at the beginning of 2025! We’re thrilled to announce that Anca-Sarmiza Gueltekin-Tigan, supported by the entire QUAREGIA GmbH - Quality & Regulatory Compliance team, has joined the PharmaBranding & Beyond network of experts! 🌟 This incredible initiative helps life science companies close gaps, scale resources flexibly, and discover innovative solutions, striving to become Austria's leading provider of interim management for life science companies. Services include: 👉 Strategic Consulting: Market strategies, business development, and market access. 👉 Quality management and regulatory consulting for medical devices, in vitro diagnostic devices, and combination products. 👉 Organizational Management: Restructuring and lean management. 👉 Activity Optimization: Enhancing product stories, launches, and team alignment. 🚀 We’re excited to collaborate with such a talented network and look forward to driving innovation together! 🤝 #LifeSciences #PharmaBrandingAndBeyond #QUAREGIA #Innovation #Collaboration 💼 Sonja Kupka-Wolf

As the holiday season 🎄 approaches, we thank you for your trust and collaboration this year. Your partnership has been invaluable, and we are truly grateful to have had the opportunity to support your projects.  🎅 Merry Christmas and a Happy New Year! May this festive season bring you and your loved ones joy, health, and success. 👉 Looking ahead to 2025, we remain at your disposal for all your needs, including: Regulatory Affairs (Strategy, CE marking, FDA approvals, international approvals) Quality Management (ISO 13485, 21 CFR part 820, MDR, IVDR) Risk Management (ISO 14971) Technical Documentation Reviews (MD, IVD, MDSW) Expert Internal Audits of your QMS Regulatory Project Management from idea to commercialization 👉 We’d love to hear from you! If you’d like to catch up or discuss any inquiries, feel free to schedule a free consultation with us here: https://lnkd.in/dDUkTCJY Wishing you a prosperous and innovative 2025! #regulatory #compliance #mdsw #ivdr #mdr #fda #2025goals

As the holiday season 🎄 approaches, we thank you for your trust and collaboration this year. Your partnership has been invaluable, and we are truly grateful to have had the opportunity to support your projects.  🎅 Merry Christmas and a Happy New Year! May this festive season bring you and your loved ones joy, health, and success. 👉 Looking ahead to 2025, we remain at your disposal for all your needs, including: Regulatory Affairs (Strategy, CE marking, FDA approvals, international approvals) Quality Management (ISO 13485, 21 CFR part 820, MDR, IVDR) Risk Management (ISO 14971) Technical Documentation Reviews (MD, IVD, MDSW) Expert Internal Audits of your QMS Regulatory Project Management from idea to commercialization 👉 We’d love to hear from you! If you’d like to catch up or discuss any inquiries, feel free to schedule a free consultation with us here: https://lnkd.in/dDUkTCJY Wishing you a prosperous and innovative 2025! #regulatory #compliance #mdsw #ivdr #mdr #fda #2025goals

As the holiday season 🎄 approaches, we thank you for your trust and collaboration this year. Your partnership has been invaluable, and we are truly grateful to have had the opportunity to support your projects.  🎅 Merry Christmas and a Happy New Year! May this festive season bring you and your loved ones joy, health, and success. 👉 Looking ahead to 2025, we remain at your disposal for all your needs, including: Regulatory Affairs (Strategy, CE marking, FDA approvals, international approvals) Quality Management (ISO 13485, 21 CFR part 820, MDR, IVDR) Risk Management (ISO 14971) Technical Documentation Reviews (MD, IVD, MDSW) Expert Internal Audits of your QMS Regulatory Project Management from idea to commercialization 👉 We’d love to hear from you! If you’d like to catch up or discuss any inquiries, feel free to schedule a free consultation with us here: https://lnkd.in/dDUkTCJY Wishing you a prosperous and innovative 2025! #regulatory #compliance #mdsw #ivdr #mdr #fda #2025goals

📢 Exciting Update for AI Manufacturers in MedTech! We’re thrilled to share the Team-NB/IG-NB Joint Position Paper on AI in Medical Devices—a must-read resource for navigating the regulatory landscape of AI-enabled healthcare innovations in the EU. Key highlights for manufacturers: 1️⃣ Lifecycle Focus: A process-oriented approach to ensure safety and compliance throughout the AI lifecycle. 2️⃣ Data Management: Emphasis on dataset quality, representativeness, and handling patient data responsibly. 3️⃣ Risk Management: Guidance on mitigating AI-specific risks, including bias, cybersecurity vulnerabilities, and model transparency. 4️⃣ Certifiability of AI: Practical tips for overcoming challenges in validating and certifying adaptive and learning algorithms. 🔗 Download the document here and align your practices with the latest best practices and standards: https://lnkd.in/dZvvMcDJ 💡 Need help with regulatory and quality compliance for AI medical devices? Book a free consultation with our experts: https://lnkd.in/dDUkTCJY. Let’s advance healthcare innovation together! 🚀 #AI #medtech #medicaldevices #notifiedbodies #requirements #compliance

FDA just issued the final guidance to provide recommendations for predetermined change control plans (PCCPs) tailored to artificial intelligence AI-enabled devices as part of marketing submissions. The recommendations in this guidance are intended to support iterative improvement through modifications to AI-enabled devices while continuing to provide a reasonable assurance of device safety and effectiveness. This guidance recommends that a PCCP describe ✔️ the planned device modifications, ✔️ the associated methodology to develop, validate, and implement those modifications, and ✔️ an assessment of the impact of those modifications.

Don't miss out on an insightful read! 🌐 📖 Our blog post provides a concise overview of how ISO 42001 can be leveraged to establish a robust compliance framework for AI in healthcare, aligning seamlessly with the requirements of the EU AI Act. 📌 In this post, we dive into: The Key Requirements of ISO 42001 How to Integrate ISO 42001 with the EU AI Act and ISO 13485 👉 https://lnkd.in/dHQ-Wr-9 #AI #Healthcare #Compliance #ISO42001 #EUAIACT #ISO13485 #TechInnovation

I will participate in the 6th AI symposium on 28 November sitem-insel School in Bern. Let's connect, if you participate as well.

🌍 Navigating Data Protection in the Medical Device Industry: EU vs. US 🌎 👉 Medical device manufacturers face complex data protection landscapes in both the EU and the US. The stakes are high, with stringent requirements around personal data collection, processing, and storage. 👉 Our blog post breaks down what manufacturers need to know about: GDPR in the EU 🛡️ HIPAA in the US 🏥 👉 We also dive into the key reporting obligations that can make or break compliance efforts. If you’re working with medical devices, this is essential knowledge for keeping both data—and your company—safe! 🔗 Read the full article: https://lnkd.in/d8md6adE #DataProtection #GDPR #HIPAA #MedicalDevices #Compliance #RegulatoryAffairs