Regulatory Basics for Medical Startups: скачать в хорошем качестве

Regulatory Basics for Medical Startups:

Are you navigating the complex world of medical device regulations? In this informative session, Natalie Vollrath, a regulatory expert with over 30 years of experience, provides an in-depth overview of regulatory basics for medical startups. Learn about the global medical device market, FDA classification and submission pathways (510(k), PMA, and De Novo), quality management systems (ISO 13485), and international compliance requirements. Gain valuable insights on avoiding common pitfalls, leveraging FDA resources, and preparing for market entry. Whether you're a startup founder or a medical innovator, this video is packed with actionable guidance to help you succeed. 🔗 Resources Mentioned: FDA 510(k) Database ISO Standards Overview IMDRF Guidance Documents 📌 Chapters: 00:00 Introduction 02:15 Global Market Insights 06:30 Medical Device Definition 10:45 U.S. Device Classifications 18:00 Regulatory Pathways Overview 28:40 Quality Management Systems 40:20 International Compliance 50:00 Q&A Session 💡 Subscribe for more insights on navigating medical device regulations and startup essentials! #MedicalStartups #FDA #Regulations #MedicalDevices #Entrepreneurship