Schlafender Hase’s Post

📢 Medical Device Report: How Are Compliance Strategies Evolving? Sponsored content from Schlafender Hase: As devices become more critical to patient outcomes, global regulatory demands in the Medical Device industry are increasing - but how are regulatory professionals adapting to the rising demands? New research has assessed how well medical device manufacturers are managing the rise of regulatory requirements. The recent study, with 202 regulatory professionals in the EU (Germany) and North America (USA), highlights the number of challenges currently competing for attention and investment and assesses device companies’ current state of regulatory readiness. Get a copy of the full report here: https://bit.ly/4dJFay2

🚨Medical Device Report: How Are Compliance Strategies Evolving? Sponsored by Schlafender Hase As medical devices play an increasingly vital role in patient care, regulatory demands are growing more complex and stringent. How are regulatory professionals rising to meet these challenges? Our latest research, surveying 202 regulatory professionals across the EU (Germany) and North America (USA), provides insights into how well medical device manufacturers are navigating these evolving requirements. From competing priorities to readiness strategies, this study offers a deep dive into the regulatory landscape. 📊 Get your copy of the full report here: https://bit.ly/4dJFay2 We are currently at Regulatory Affairs Professionals Society (RAPS) Convergence (Booth 822) — today’s the last day! Don’t miss your chance to stop by and chat with us.

Are Medical Device Suppliers Equipped for the Escalating Regulatory Landscape? The global medical devices market is projected to surpass $886 billion by 2032. As these devices become increasingly critical to patient outcomes, regulators are tightening their quality and safety expectations. But how well prepared are suppliers to meet these rising standards? We recently commissioned independent research to find out. The 2024 study surveyed 202 regulatory professionals at Class 2 and 3 medical device companies in Germany and the US. The findings highlight several key challenges and assess the current state of regulatory readiness among device suppliers. Read the article here: https://lnkd.in/ezWnaknB

PN Update: Expediting regulatory guidance for RWE in medical devices: Why it matters for patients

It's concerning to hear that a significant percentage of IVD (28%) and medical device (48%) manufacturers are deprioritizing the EU market due to the unpredictability of the IVDR and MDR in terms of time, cost, and regulatory changes.

The regulatory landscape for medical devices is continuously evolving, leading to significant challenges for manufacturers including intricate regulatory procedures. Our whitepaper breaks down the latest developments you need to know about: https://hubs.li/Q02yvrlN0 #medicaldevices

🎙️The new episode of #MedTechONAIR is live! ⏳13 mins to understand how Europe’s regulatory system for medical technologies could be improved to better serve patients’ needs +? In this episode, we discuss with Director of Regulatory Affairs, Petra Zollner, MedTech Europe’s vision on how to tackle existing challenges in Europe’s regulations for medical technologies (Medical Devices Regulation and In-Vitro Diagnostics Devices Regulation) and our recommendations on how to move our #healthcare systems forward. 🎧Listen here: bit.ly/MTOAS4E3  

MEDIcept Minute: New FDA Draft Guidance – Enhancing Medical Device Development with Patient Preference Information The FDA is shaping the future of patient-centered innovation—are you ready to incorporate patient preferences into your medical device strategy? Last Thursday, September 5th, 2024, the FDA issued a new draft guidance on incorporating voluntary patient preference information (PPI) over the total product life cycle. This update provides recommendations on how patient preferences can be collected and considered in regulatory decision-making. It builds on the 2016 guidance and offers fresh insights into the role of patient preference studies, helping medical device companies incorporate these preferences throughout the product's lifecycle. Public comments on this draft are encouraged until November 5, 2024. Click the link below to learn more about this draft guidance. https://lnkd.in/eyaTr__A To stay compliant and ensure your product is aligned with these new regulations, contact MEDIcept Inc. at sales@medicept.com for expert guidance in navigating this update. #MedicalDevices #FDAUpdates #PatientCenteredCare #RegulatoryAffairs #PPIGuidance 

🎧 Upcoming Webinar: Regulatory and Clinical Feedback from Notified Body Assessment – Best Practices and Benchmarks 📅 September 12, 3 PM CET 🔗 Register now: https://lnkd.in/dHGTm9fa Gain practical knowledge that will help you navigate the evolving regulatory landscape effectively. Join our Medtech Commercial Director Lebon Aymeric for an in-depth analysis of regulatory and clinical feedbacks from NB assessments and the best strategies for ensuring compliance in the medical devices sector. We believe the insights and strategies shared during this session will be of great value to your team. #webinar #medtech #notifiedbodyassessment #regulatoryaffairs #clinicalfeedback #compliance #medicaldevices #bestpractices

🎧 Unlock the secrets to successful regulatory compliance in MedTech! Our webinar on September 12 dives deep into the feedback from NB assessments. Whether you're just starting or refining your process, this is for you! 😊 📅 Save the date: September 12, 15PM CET 💬 Share your experience! What has been your biggest challenge in MedTech compliance? 🔗 Don't miss out – Register today: https://lnkd.in/dHGTm9fa 📲 If you want to see a preview of our capabilities in MedTech, check out this interview with Aymeric Lebon and Charlène TRAVERS-CHEVALIER.: https://lnkd.in/dtuchd7S #webinar #medtech #notifiedbody #clinical #bestpractices #medicaldevices #regulatoryaffairs #medicalregulations #healthcareindustry #medtechinnovation #qualityassurance #regulatorycompliance #clinicalresearch #regulatoryupdates #medicaltechnology #healthtech #healthcarecompliance #medicaldeviceindustry #compliancemanagement #webinarevent #healthcarewebinar #deviceapproval #clinicaltrials #regulatorystrategy #regulatoryinsights #webinar