Activité
-
Un dossier très complet pour tout savoir !
Un dossier très complet pour tout savoir !
Aimé par Marion DANSETTE
Expérience
-
-
-
-
-
-
-
-
-
Formation
-
Polytech Lyon
-
-
-
Semestre d'échange (6 mois)
-
-
Langues
-
Anglais
Capacité professionnelle générale
Autres profils similaires
Découvrir plus de posts
-
EXTEDO
EXTEDO at RAPS Euro Convergence 2024 – join our sessions! RAPS Euro Convergence 2024 is where innovation meets collaboration to shape the future of healthcare regulation! Join us on 07 May 2024, as our experts take the stage to share their insights: 🕙 09:50 - 10:50 CEST: "Emerging Advancements in eCTD: A Panel Discussion on Cloud Integration, Data Standards, and Publishing Perspectives in Regulatory Submissions"- featuring Frank Dickert, Senior Business Consultant at EXTEDO. In this presentation, Frank will discuss the benefits of early adoption – increased regulatory efficiency, reduced administrative burden, and a comprehensive view of product lifecycles. You will gain actionable strategies and insights to propel your organization forward! 🕒 15:05 - 16:05 CEST: "From China to WHO: Strategies & Updates to Accelerate China & WHO Drug Approvals and Master Files" featuring Gerhard Neurauter, Vice President Regulatory Competence Center at EXTEDO. Explore the intricacies of eCTD with WHO as Gerhard guides you through the registration process, submission requirements, and the latest Module 1 updates. Discover how to streamline your submission process and overcome implementation challenges with expert guidance and support. You can not attend the sessions and would like to learn more about how EXTEDO can support your organization's regulatory journey? Just reach out to Frank and Gerhard to schedule an individual appointment! #EXTEDO #RAPSEuroConvergence #IDMP #eCTD #WHO
-
BGS Beta-Gamma-Service GmbH & Co. KG
The path to a sterile product requires validation. When it comes to radiation sterilization, this is regulated by the process standard DIN EN ISO11137. Learn more about the whole process on our website ➡️ https://lnkd.in/evJAP4u #bgs #bgsbetagammaservice #irradiation #qualityassurance
-
CLIN-r+
📑 How well do you understand CER, SSCP, and PSUR under EU MDR?? 📑 Navigating the complex regulatory landscape of the EU Medical Device Regulation (EU MDR) can be challenging. To help you understand the key differences between the Clinical Evaluation Report (CER), Summary of Safety and Clinical Performance (SSCP), and Periodic Safety Update Report (PSUR), we've put together our whitepaper: "CER, SSCP, and PSUR: What's the Difference?" This comprehensive whitepaper breaks down the purpose, content, and requirements of each report, ensuring that your medical devices remain compliant throughout their lifecycle. Key highlights include: ✅ Clear Distinctions: Learn the unique roles and overlaps between CER, SSCP, and PSUR. ✅ Regulatory Compliance: Ensure your documentation meets EU MDR standards to avoid non-compliance issues. ✅ Strategic Insights: Gain practical advice on creating and maintaining these critical reports. 👉 https://lnkd.in/ez_T-fm4 #EUMDR #MedicalDevices #RegulatoryCompliance #Whitepaper #CER #SSCP #PSUR #MedTech #HealthcareInnovation #practicaladvice #strategicinsights
-
NAMSA
🔍 Are you up to speed with PMCF obligations under the EU MDR for your medical devices? NAMSA's Expertise in PMCF Can Guide You Through: 📊 Strategizing Data Collection: What data to collect, and the best ways to gather it 🗺️ Detailed Planning: Developing a plan that ensures efficient execution of the strategy 📌 Efficient Data Collection: Implementing systematic methods for data acquisition, while ensuring accuracy and relevance of the information collected 📝 Robust Reporting: Preparing a PMCF report tailored to meet Notified Body expectations Don't navigate the complexities of PMCF alone! Discover how NAMSA can support your compliance journey and enhance your market success. https://lnkd.in/ghEtDuvZ #PMCF #PMCFStrategy #PMCFPlan #PMCFReport #PMCFStudy #MedicalDevices #MDR #NAMSAKnows #CRO
-
CLIN-r+
🔍 EU MDR Readiness Checklist 🔍 Navigating the complexities of the EU MDR can be daunting, but CLIN-r+ is here to help. Drawing from extensive consulting experience, this white paper provides a practical, actionable checklist to ensure your compliance with the new regulations. We cover critical areas such as assessing your situation, reviewing your Quality Management System, aligning with the Technical Documentation structure, and evaluating product compliance. Additionally, we offer insights into necessary validations, standards, and formulating a comprehensive action plan. Our goal is to equip you with the knowledge and tools needed to streamline your MDR transition and avoid common pitfalls. Don't miss out on this essential guide to ensure your MDR readiness and stay ahead of the regulatory curve: https://lnkd.in/e47MGzqX #EUMDR #RegulatoryCompliance #MedicalDevice #HealthcareInnovation #keytosuccess #technicaldocumentation #regulatoryaffairs #medtech #medicaldeviceregulation #regulatorycompliance #euregulation
