Upcoming Webinars and Events
We’re putting webinars on hold for the holiday season, because who wants to watch a webinar when there is turkey to eat, cookies to bake and gifts to buy?
But fear not. We’ll be back in 2026 with an exciting lineup of webinar topics. Happy Holidays!
November Featured Video:
Design controls aren’t just paperwork — they’re how you prevent recalls, reduce risk, and build devices that actually work as intended. In this session, you’ll learn how to integrate design controls and risk management — two of the most misunderstood yet essential pillars of medical device development — to create safer, more compliant products. Discover practical strategies to meet QMSR expectations, implement risk analysis using ISO 14971, and develop a design history file (DHF) that tells your device’s story from concept to commercialization. You’ll also learn how to create trace matrices that make your design process clear, defensible, and auditor-friendly.
Watch it here: https://youtu.be/Pn9WuGhLFds
Missed a Webinar? Check Out Our Archives
A candid, interactive discussion on what’s really happening inside the FDA in 2025—from shifting review standards to real-world case studies. Walk away with practical insights to avoid pitfalls and accelerate your FDA engagement.
Most MedTech startups underestimate what it really costs to reach FDA clearance. In this session, Renae Franz of leanRAQA breaks down the true expenses of development, testing, submission, and commercialization—plus how to stage funding, avoid cash flow traps, and build a financial plan that wins with both regulators and investors.
What’s the real difference between “state of the art” and “standard of care”—and why does it matter for medical devices? This session unpacks how regulators interpret each term, how they show up in ISO 14971, and what that means for design, safety, and risk management.
Michelle and Adam Foresman of Ryden Solutions dive into lean quality systems, regulatory shifts, and the rise of AI-driven compliance in MedTech. From audit war stories to the hidden costs of over-documentation, they explore QMSR, MDR, and why global harmonization is unraveling—plus how AI is already reshaping audits and compliance strategies.
Bringing a medical device to market takes more than innovation—it requires a solid commercialization plan from day one. This session breaks down the real-world barriers that derail startups, from missed user validation to underestimating time-to-revenue and funding needs. Walk away with practical strategies to avoid costly delays and set your device up for market success.
Did you know 60% of startups don’t make it past five years—and 75% eventually fail? This video unpacks the critical stages of medical device development, from regulatory strategy and design for manufacturability to commercialization and IP protection. With real-world examples and practical insights, it’s a must-watch for MedTech innovators aiming to beat the odds.
