From Band-Aids to Pacemakers: Pure Global's Ultimate Guide to Medical Device Classification and Navigating Your Regulatory Journey. cover art

From Band-Aids to Pacemakers: Pure Global's Ultimate Guide to Medical Device Classification and Navigating Your Regulatory Journey.

From Band-Aids to Pacemakers: Pure Global's Ultimate Guide to Medical Device Classification and Navigating Your Regulatory Journey.

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 This episode of MedTech Global Insights dives into the most critical first step for any medical device manufacturer: classification. Discover why determining if your device is Class I, II, or III is the single most important decision that dictates your budget, timeline, and path to global market access. We explore the nuances of each classification with real-world examples, from simple Class I devices to life-sustaining Class III implants. Learn about the common pitfalls that can delay your launch by months or even years, and how regulatory requirements for the same device can differ dramatically between major markets like the United States and Europe. A promising scale-up with an innovative infusion pump targeted both the US and EU markets. A subtle difference in classification between the FDA's Class II and the EU's Class IIb designation led to a six-month delay and unexpected costs for additional clinical data. This episode dissects how to avoid such pitfalls. What you'll learn in this episode: - Why is device classification the single most important decision in your regulatory strategy? - What are the key differences between Class I, II, and III devices, with real-world examples? - How can a device be Class II in the US but a higher risk class in Europe, and what does that mean for your budget? - What common mistakes do startups make when classifying their first device? - How do you determine the correct classification for a device that uses novel software or AI? - What are "special controls" and when do they apply to your product? - Why is a Premarket Approval (PMA) for Class III devices so much more challenging than a 510(k)? - How can you leverage your device's classification in one country to accelerate access to over 30 other markets? Contact us at info@pureglobal.com or visit https://pureglobal.com/ for more information.
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