MedTech Leading Voice

Ramping up your 2025 Market Access Strategy 🇺🇸 A Roadmap for Medical Device Compliance & Commercialization 👇👇 Prepare your medical device for a successful launch in the US by joining us for an in-depth exploration of market access strategies to accelerate regulatory review, reimbursement, and market adoption. This webinar is tailored for medical device companies (devices, diagnostics, SaMD, digital therapeutics, AI-based algorithms) preparing to enter the US market in the next 2-5 years, with a focus on what you should be doing now to facilitate FDA engagement, payer interaction, evidence development, and provider/patient advocates for your technology. Gain insights into prioritizing resources effectively to accelerate your device’s path to market, including tips on establishing milestones to ensure reimbursement at the time of regulatory approval. Our experts will discuss setting strategic priorities that you can execute successfully in a manner consistent with your corporate culture, and available personnel and financial resources. Key topics will include: ✅ Strategic resource allocation in 2025 calibrated to your market launch timeframe ✅ Effective engagement with FDA, payers, and target customers ✅ Developing clinical and economic evidence efficiently for use with multiple audiences  ✅ Leveraging US regulatory and payer engagement to accelerate adoption in global markets -️ Date and Time: Thursday, Dec. 5, 2024 - 11:00 AM ET / 5:00 PM CET.* *Recording available to all registrants. #marketaccess #medtech #fda #medicaldevices #strategy #510k

Upcoming Webinar: Maximizing Structured Dialogue for MedTech How to achieve greater clarity and build stronger relationships with notified bodies >>> Register Now! Structured dialogue is potentially one of the most valuable tools for medical device and IVD manufacturers working with notified bodies. It provides a chance for manufacturers to understand the requirements for clinical evidence and avoid common pitfalls in MDR and IVDR compliance. But to make the most of it, manufacturers need a clear understanding of the process, its limitations, and how to prepare effectively. Join us on Tuesday, November 26, with subject matter experts Bassil Akra, Marta Carnielli, Alex Laan, Michelle Lott, RAC, and Tom Patten as we explore: ✅ The Purpose and Boundaries of Structured Dialogue: Understand what structured dialogue can—and can’t—do in clarifying regulatory expectations without crossing into consulting. ✅ Effective Preparation: Learn how to ask targeted questions and present your information clearly to get the insights you need within the structured dialogue process. ✅ Working Within the Process’s Limitations: Discover methods for structuring your presentation to avoid issues, even with questions that notified bodies are not permitted to answer. ✅ Contrasting the U.S. FDA’s Pre-Submission Meetings: See how structured dialogue compares with the FDA’s approach and the benefits of each for MedTech and IVD manufacturers. Interactive Q&A: This session is your chance to ask difficult questions and hear honest answers from leading experts, including both current and former notified body representatives. #raps #medtecheurope #eumdr #ivdr #structureddialogue #fda

This Friday’s Interactive Session on Real-World Evidence 👇👇 Only on MDG Premium: Where the experts meet. Join us for a lively new session with Amelia Hufford, Ph.D., co-founder of 3Aware, as she shares how Real-World Evidence (RWE), including the use of electronic health records at scale, is transforming MedTech compliance and product strategy. Learn how RWE is reshaping post-market surveillance, reducing compliance timelines, and driving informed product development. ✅ Strategies to use RWE to reduce compliance time and costs ✅ Guidance on expanding device applications and accessing new markets with data-driven insights ✅ Methods to leverage RWE for more targeted and responsive product R&D Gain insights directly from a leader in MedTech innovation and compliance, and discover actionable steps to integrate real-world evidence in your own processes. 📅 Date: Friday, November 15, 2024, 11 a.m. ET (1 hour) *Recording available to all registrants. #MedTech #Webinar #RealWorldEvidence #PostMarketSurveillance #RegulatoryCompliance #MedicalDevices #ProductDevelopment #3AWARE #MDGPremium

New Generative AI Workshop (FREE) Join MedTech Leading Voice and guest speakers Martin King and Mark Omo for an interactive one-hour workshop to explore how Generative AI tools, including ChatGPT, Bing, Copilot, and others, can transform the regulatory and quality workflows for MedTech professionals. This session will show how these tools can streamline tasks, from real-time search and risk management to quality system documentation, helping you work faster and more effectively. ✅ Overview of Generative AI Tools: Understand the capabilities of ChatGPT, Bing, Copilot, and other AI tools and how they differ in functionality. ✅ Practical Applications in MedTech: See how these tools can be applied to specific tasks in regulatory affairs and quality management, such as drafting documents, organizing information, and interpreting regulatory guidelines. ✅ Live Demonstrations: Watch real-time demonstrations of these tools in action, showing how to incorporate AI into your daily workflow with examples relevant to risk assessment, regulatory research, and quality systems. ✅ Best Practices for Effective Use: Gain tips for crafting prompts and setting up workflows to get the most out of these AI tools without compromising on accuracy or compliance. Click below to register. #medicaldevices #raps #genai #ai #workshop #regulatory

Biocomp Beyond the Basics Coming THIS Thursday👇👇 Join MedTech Leading Voice and four leading subject matter experts: - Marina Daineko - Damian Matak - Łukasz Szymański - Michelle Lott, RAC For an insightful one-hour webinar as we explore the latest revisions in ISO 10993 for biocompatibility testing, going beyond the basics to cover essential updates affecting medical devices and in vitro diagnostics. This session will focus on both the U.S. and EU perspectives, highlighting areas of alignment, divergence, and the implications for manufacturers working in these markets. Key Sections in Focus: We’ll discuss significant changes in critical parts of ISO 10993, including: ✅ ISO 10993-1 (General Requirements) ✅ ISO 10993-4 (Hemocompatibility)  ✅ ISO 10993-17 (Toxicological Risk Assessment) ✅ ISO 10993-18 (Chemical Characterization) ✅ ISO 10993-23 (Skin Sensitization) Comparative Analysis: Understand how these changes are interpreted differently by the FDA and EU regulators, with insights into each region’s specific requirements and current guidance. Practical Implications: Gain expert advice on how to navigate these revisions to ensure compliance, including tips on document preparation, risk assessment, and data presentation. Why Attend? This session will clarify complex biocompatibility requirements, helping you prepare for a smoother regulatory pathway. You’ll have the chance to ask questions directly to leading subject matter experts and learn best practices for aligning with both U.S. and EU standards. #biocompatability #medeicaldevices #sterilization #toxicology #iso10993

I'm so excited for this Friday's Medical Device Group (MDG) call... Featuring Guest Speaker Georg Digel ("The CAPA Guy")👇👇 "Common CAPA Issues vs. LinkedIn Engagement" Are people seeking solutions or entertainment? In case you don't know about J o e H a g e's MDG Friday calls, they are "one-of-a-kind," interactive webinars featuring a wide range of MedTech professionals--experts sharing their real-life experiences--in a dynamic Zoom setting. Register below to join us! #CAPA #medicaldevices #regulatoryaffairs #raps #linkedin

There is still time to enroll in MedTech Startup School and save! Free 4-week course: "Fundamentals of FDA Clearance & Compliance"👇👇 Enroll by Dec. 1 Instructor: Michelle Lott, RAC See full course details below >> #medtechstartup #510k #fda #presubmission #estar #qmsr

There is only one day left to register for the Device Claims Masterclass👇 Save your spot: https://lnkd.in/eMft9un2 Are your marketing claims putting your medical device at risk of being flagged by regulators? Join Michelle Lott, RAC, an expert in regulatory compliance, for an in-depth understanding of what you can and cannot say when marketing medical devices. During this session, Michelle will cover critical insights on how to make compliant claims, avoid common missteps, and navigate the complex regulatory landscape around medical device claims. Key Topics Covered: • Common mistakes companies make with medical device claims • What the FDA and FTC say you can and cannot claim • Navigating promotional materials and labeling • Best practices for ensuring compliant marketing strategies • Real-world examples of claim violations and their consequences Why Attend? Participants will not only gain insights into regulatory compliance for medical device claims but will also receive: • A Certificate of Attendance • Access to a Recording and Slides of the webinar • A bonus: You Can’t Say That! "Cheat Sheet" to guide your claim-making process Speaker: Michelle Lott, Founder and Principal, lean RAQA Date: Thursday, October 10, 2024* Time: 12:00 noon ET (1-hour webinar) *Recording available to all registrants Register now to ensure your spot in this critical masterclass! Presented by MedTech Leading Voice and MedTech Intelligence. #fda #claims #cdrh #ftc #medtechstartups

🚀 Join five experts in Boston on Oct. 28 for a half-day symposium on Real-World Evidence for Medical Devices. 👇👇 RWE-Driven MedTech Symposium: Achieving Reliability & Relevance with Real-World Data Capacity is limited to 45 seats - Register Now! ✅ Notified Body View: RWE Value in Meeting EU Pre- and Post-Market Clinical Data Requirements - Diane Legere RN, BSN, MSc, APCCN ✅ Real-World Data Collection to Fulfill Global Evidence Needs - Trevor Carden, ✅ Using RWE for Entering New Markets - Bethany Knorr Chung, PhD, RAC, RQM+ ✅ EU MDR: State of Play in 2024 - Bassil Akra, PhD  ✅ Leveraging RWE to Optimize Device Profitability - Amelia Hufford, PhD, Q&A Panel Discussion - All Speakers Networking Lunch #RWE #medicaldevices #notifiedbody #eumdr #postmarketsurveillance

This is going to be great! Join Michelle Lott, RAC, MedTech Intelligence, and me on Oct. 10th for a masterclass on device claims. #fda #claims #medicaldevices