Attention MedTech Professionals! Are you ready to unlock the secrets of post-market surveillance (PMS) and take your device safety and performance to the next level? Introducing "Mastering Post-Market Surveillance," the eBook that will revolutionize your approach to PMS.
In the first 3 chapters, we dive deep into the WHY and HOW of PMS. It's not just a regulatory checkbox, but a powerful tool that connects device manufacturers with real-world outcomes.
Chapter 1: Understanding the Intended Use and User
Discover why a thorough grasp of the intended use of a device is crucial for ensuring effectiveness and safety throughout its lifecycle. 🩺 Uncover the foundation it provides for customer feedback, addressing legal liabilities, and more!
Chapter 2: Predicate Devices & Competitors
Learn how to leverage predicate devices as references to prove safety, effectiveness, and gain credibility. 📊 Uncover the importance of competitor analysis and how it helps you highlight your device's strengths, market gaps, and unique advantages.
Chapter 3: PMA & de novo Pathways
Navigate the intricate landscape of FDA approvals and gain insights into PMA and "de novo" pathways. Discover the pathways tailored to the risk profile and novelty of your device, and understand the challenges and potential breakthroughs they offer.
Mastering Post-Market Surveillance is your passport to excellence in device safety, regulatory compliance, and business success.
Don't miss out on this opportunity to elevate your PMS game and make a lasting impact in the medical device industry!
Ready to dive in? Download your copy of the eBook today and join the league of PMS champions. Download your free copy here