Скачать или смотреть How much clinical data do you actually need: Have we overestimated the EU requirements?

In the complex landscape of EU regulatory compliance, one question keeps emerging: Do you actually need clinical data for your medical device? For MedTech professionals, understanding what’s required versus what’s commonly assumed can mean the difference between streamlined compliance and unnecessary effort. In this webinar, we’ll take a close look at EU regulations to clarify when clinical data is truly necessary, and when it may not be required at all.

Join us to uncover the real standards behind EU compliance, helping you make informed decisions about your clinical data strategy.

Specifically, this webinar will help you with:

What’s Required and What’s Not: Get a clear understanding of when clinical data is truly necessary for compliance.
Navigating Requirements for Different Device Types: Learn about specific requirements for software as a medical device (SaMD), low-risk devices, and orphan devices.
Avoiding Unnecessary PMCF: Discover when post-market clinical follow-up (PMCF) is essential, and when it can be scaled back or avoided.
Right-Sizing Your Clinical Strategy: Understand the regulatory standards that let you streamline your approach, saving time and resources.

Learn more: https://www.greenlight.guru/webinar/h...