CLIN-r+

📣Just 1 MONTH LEFT until the 2nd Annual Medical Devices Regulations & Safety 2024!!📣 We hope you can join our Director of Clinical and Regulatory Affairs, Jacqueline van Druten ONLINE. She'll be discussing how you can ace your submission with focus on EU MDR Clinical Evaluation Conformity routes and giving crucial insight into what you need to know for your legacy and new products. 👍You can join us from the comfort of your own office!!👍 Plus, because we always enjoy a catch-up and chat, you are also welcome to make an appointment with us in advance to discuss your regulatory or clinical affairs needs to obtain your MDR CE mark or your GREEN transition. During the event, we will also be offering clients a free 40-minute consultation (at the event or virtually) to discuss your most pressing EU MDR Clinical Regulatory questions. ✅Book your free call now: https://lnkd.in/eDYK7hj3 #onlineevent #medtech #strategicplan #thoughtleaders #medicaldevice #regulatoryaffairs #eumdr #safetyevaluation #performanceevaluation #medicaldeviceregulation #regulatorycompliance #euregulation

✨Stay compliant and ensure patient safety with effective post-market surveillance✨ This blog post dives into the requirements of Post Market Surveillance (PMS) for medical devices under the EU Medical Device Regulation (MDR). The MDR requires manufacturers to have a plan in place to monitor the safety and performance of their devices after they have been placed on the market. This includes collecting and analyzing data on device performance, adverse events, and complaints. By following the MDR's PMS requirements, manufacturers can: ✅Improve patient safety ✅Identify and address potential risks ✅Demonstrate regulatory compliance This whitepaper is a valuable resource for anyone involved in the medical device industry, including: 👉Medical device manufacturers 👉Regulatory affairs professionals 👉Quality assurance professionals 👉Click the link below to learn more about effective post-market surveillance. Effective Post-Market Surveillance for Medical Devices https://lnkd.in/ew3Tm_SF

The MDR has raised the bar for data quality and quantity. Staying on track with Post-Market Clinical Follow-Up (PMCF) planning is crucial. From our client collaborations, we've spotted recurrent issues that, if unaddressed, could impact business significantly. To enhance competitiveness, this document sheds light on these issues. Additionally, it outlines three major compliance best practices. Our white paper guides manufacturers through preparation, steps, and the three key pitfalls often encountered by CLIN-r+. It emphasises bridging gaps found in CER or emerging risks from PMS into the PMCF plan, strengthening the foundation for regulatory success. https://loom.ly/OrzxzYA #MDRCompliance #PitfallPrevention #bestpractices #pms #pmcf #mdr #technicaldocumentation #medicaldevice #regulatoryaffairs #medtech #cemarking #clinicalevaluation #safetyevaluation #performanceevaluation #regulatorycompliance #euregulation

❓Are you a medical device manufacturer prepared for EU MDR Post-Market Clinical Follow-up (PMCF)❓ With the EU MDR in full effect, ensuring compliance with PMCF requirements is crucial. Our CLIn-r+ FAQ resource page is designed to help you navigate the complexities of PMCF and pass your upcoming audit reviews. Key topics covered: ✅PMCF Plan Development ✅Data Collection and Analysis ✅Risk Management and Clinical Evaluation ✅Reporting Requirements https://lnkd.in/ex3E5uQG #EUMDR #PMCF #MedicalDevices #RegulatoryCompliance #ClinicalTrials #ClinicalResearch #RegulatoryAffairs

🌟 Fast-Tracked PMCF Activities for EU MDR Submission 🌟 When it comes to medical device regulation, securing compliance with the EU MDR can be a formidable challenge. Our case study showcases an innovative solution for overcoming regulatory hurdles. 🌎Case Study Highlights🌎 An innovative Australian MedTech company specializing in incision management solutions engaged CLIN-r+ to resolve a major non-conformity and support their EU MDR transition. Faced with inadequate post-market surveillance (PMS) activities and no prior experience in conducting post-market clinical studies in Europe, the company needed to fast-track their clinical data acquisition. The Challenge: 🔴 Close off a significant non-conformity impacting EU MDR transition. 🔴 Implement a robust Post Market Clinical Follow-Up (PMCF) plan to meet clinical data requirements. 🔴 Achieve EU MDR readiness within 6 months. 🔴 Navigate through the lack of clinical data due to no previous PMCF activities. The CLIN-r+ Solution: 🟠 Rapid Implementation: Delivered a live virtual platform within 48 hours and a centralized project plan for seamless stakeholder collaboration. 🟠 Gap Assessment: Conducted a thorough review of the MDD Technical file and QMS procedures, identifying efficiencies and compliance gaps. 🟠 Comprehensive PMCF Plan: Developed a time-bound project plan to meet the EU MDR readiness audit deadline. 🟠 SOP and Template Remediation: Remediated PMS, Clinical Evaluation, Risk Management, and Clinical Investigation SOPs and templates. 🟠 Continuous Support: Managed weekly huddles, provided real-time progress updates, and facilitated global implementation across 3 continents. The Deliverables: 🟢 Updated Clinical Evaluation Report, PMCF plan, Clinical Investigation plan, and PMCF Report. 🟢 Compliance with EU MDR, IMDRF, MDCG guidance, ISO standards, and MEDDEV 4.7.1rev4. 🟢 Live project plan dashboard for transparent progress tracking and collaboration. 🟢 QMS process remediation across PMS, Clinical Evaluation, Risk Management, and Clinical Investigation workflows. The Benefits: ☑️ Cost-effective delivery of PMCF Plan, Clinical Investigation Plan, and CRO execution. ☑️ Rapid delivery of compliant PMCF and Clinical Evaluation reports. ☑️ No findings on the MDR Readiness Audit. ☑️ Successful EU MDR transition with CE mark achieved within the ambitious launch date. 👉 Read the Full Case Study Here: https://lnkd.in/ebQ_8Bt7 👈 By partnering with CLIN-r+, our clients proactively implement strategic goals well in advance of deadlines. We keep projects on track, ensuring all gaps are closed and providing support where it’s needed most. Sound interesting? Get in touch! https://lnkd.in/epCyVJ3a #EUMDR #PMCF #MedicalDevices #RegulatoryCompliance #CaseStudy #MedTech #HealthcareInnovation #ClinicalEvaluation

🔍 Introducing our FAQ on compiling your Device #TechnicalDocument under EU MDR! Curious about how to structure and the content of the TD their importance under the EU Medical Devices Regulation? Our FAQ covers everything you need to know, including: ✅ How to structure a TD to be compliant. ✅ What content should be in each section ✅ How does it differ form the MDD and a FDA dossier. ✅ The role of harmonised standards and validation testing. Gain insights into how a well-structured #TechnicalFile can streamline your products #MDR #CE assessment. That can fast track your device development, ensure regulatory compliance, and facilitate market entry. https://lnkd.in/eu2Rpivc

Did you know that you can book a complimentary review with us? You should contact us if: ❓You don’t have the in-house resources or expertise. ❓You have deficiency findings. ❓You need support transition from MDD to EU MDR. ❓You want to work with a consultancy that’s an extension of your business. Contact us, start that discussion, and realise the difference! 🌟 https://loom.ly/Le2QfCY

📢 Top MDR Submission Feedback: What Could Delay or Risk Your EU MDR Technical Document Assessment 📢 This comprehensive document encapsulates valuable insights and expert knowledge gathered from numerous MDR regulatory submissions. CLIN-r+ shares these learnings to support manufacturers in their MDR submission processes, highlighting key feedback from MDR-notified body technical documentation audits. Discover stringent regulations, common nonconformities in device description, testing, risk management, and post-market surveillance, and how to effectively address deficiency reports. Our recommendations will guide you in navigating the complexities of MDR compliance, ensuring a smooth and successful submission. Don’t miss out on this essential resource for your regulatory journey: https://lnkd.in/eQUSBdz5 #MDRCompliance #MedicalDevice #RegulatoryAffairs #HealthcareInnovation #valuableinsights #eumdr #riskmanagement #keytosuccess #technicaldocumentation #medtech #medicaldeviceregulation

⚠️Don't Get Stuck in EU MDR Technical Documentation Purgatory: Get Expert Help ❓Is your EU MDR technical documentation a tangled mess, threatening to stall your CE marking journey? The complexity of EU MDR requirements can leave even seasoned medical device professionals feeling overwhelmed. The good news is, you don't have to navigate this alone! CLIN-r+ offers a comprehensive solution to streamline your technical documentation process. Here's how we can help you achieve EU MDR compliance with confidence: ✅Expert guidance: Our experienced team provides in-depth understanding of EU MDR technical documentation requirements. ✅Streamlined process: We guide you through each stage, ensuring all necessary information is documented accurately and efficiently. ✅Clear and concise: We ensure your documentation is clear, concise, and easy for Notified Bodies to understand, reducing review times. ✅Reduced risk: We help mitigate potential regulatory risks associated with incomplete or non-compliant documentation. ⏰Stop wasting time and resources struggling with technical documentation on your own. Let CLIN-r+ be your trusted partner in achieving EU MDR compliance. Ready to get started? Download our free guide: "The Ultimate Guide to EU MDR Technical Documentation" for a comprehensive breakdown of the requirements on our site. ✉️Contact CLIN-r+ today! Schedule a free consultation with our experts and discuss your specific needs. #EUMDR #TechnicalDocumentation #CEMarking #MedicalDevices #RegulatoryAffairs #CLINrPlus #YourTrustedPartner

✨Conquer EU MDR Complexity: Master Technical Documentation Structure✨ ⚠️Don't let technical documentation become a roadblock to your CE marking goals.⚠️ 🚀Empower yourself with the knowledge to structure your documentation for success! Let's connect in the comments below! Share your biggest challenges with structuring your technical documentation and ask any questions you have. We're here to help! https://lnkd.in/ej7NfVAy 👊