Upstate Medical University

Greenlight Guru Presents: Pre-Market Medical Device Studies and GCP Strategies for Success Webinar

May 30, 2023 at 9:00 AM

Pre-Market Medical Device Studies and GCP - Strategies for Success

Good Clinical Practice (GCP) requirements ensure that pre-market medical device studies meet ethical, scientific, and regulatory standards.

US FDA and the EU Medical Device Regulation require clinical investigations conducted for medical devices to follow GCP guidelines in order to ensure the quality and integrity of data generated during the study.

But what does GCP and the ISO14155 standard ask of device manufacturers exactly, and what are the main strategies for successfully fulfilling these requirements?

Join us for this free webinar presented by Jon Bergsteinsson, SMART-TRIAL by Greenlight Guru co-founder, and Maria Nyåkern Ph.D. CEO at ACR Consulting, to find out what the main requirements are for GCP and why it is important for medical device studies.

We encourage you to join live, for the chance to get your questions answered directly by Maria Nyåkern, who is a subject matter expert in clinical evaluation and clinical investigations of medical devices according to the EU MDR 2017/745 and the ISO 14155:2020 standard.

Pre-Market Medical Device Studies and GCP - Strategies for Success
Specifically, this webinar will cover:
  • Key differences between the US FDA and European GCP requirements
  • Minimal requirements for a Clinical Investigation Protocol (CIP)
  • How to translate a protocol to a clinical data capture strategy
  • Optimizing data collection for data analysis
  • Budget considerations for clinical studies
  • Critical roles needed to be able to run clinical studies
Who should attend? 
  • All medical device companies currently running or planning pre-market clinical studies.