A Comprehensive Guide to Clinical Investigations with Medical Devices in Europe: Pre- and Post-Market Requirements
🔍 In this whitepaper, you’ll find detailed insights on:
- The regulatory landscape for clinical investigations in Europe, covering pre-market and post-market requirements under MDR 2017/745
- The different stages of clinical development according to ISO 14155:2020, including pilot, pivotal, and post-market studies
- Submission procedures, risk management, and reporting obligations throughout the clinical investigation process
💡 Why download our whitepaper?
- Gain a clear understanding of the clinical investigation requirements under MDR 2017/745
- Learn how to navigate submission processes, including applications and notifications across different EU Member States
- Discover best practices for managing risk, setting up a Data Monitoring Committee, and ensuring compliance with reporting obligations
Don’t miss this essential guide for medical device manufacturers! Click the link below to download and stay informed on conducting safe and compliant clinical investigations in Europe.
