May 30, 2023

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.

Watch the webinar

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.  
Register Now  

Hosted by

Jón Ingi Bergsteinsson headshot
Jon Bergsteinsson

Co-founder & leading MedTech voice,
SMART-TRIAL by Greenlight Guru

Maria N headshot
Maria Nyåkern

Chief Executive Officer,
ACR Consulting

Etienne Nichols

Medical Device Guru
Greenlight Guru


About Greenlight Guru

Greenlight Guru is the leading cloud-based platform purpose-built for MedTech companies. The end-to-end solution goes beyond traditional QMS needs by integrating cross-functional teams, processes, and data throughout the entire product lifecycle so device makers can proactively overcome execution gaps, streamline compliance, and accelerate market success.

Greenlight Guru’s platform is used by organizations across the globe that are replacing their disjointed, legacy tools and solutions to bring life-changing products to people faster, and with less risk.

Visit our homepage to learn more.

smart-trial by greenlight guru logo

About SMART-TRIAL by Greenlignt Guru

The only Electronic Data Capture (EDC) platform designed for Medical Devices & Diagnostics. SMART-TRIAL offers the ideal Electronic Data Capture for clinical investigations, performance studies, and PMCF/PMPF activities - including registries and surveys. SMART-TRIAL is built to empower clinical teams to be their best, and in full control of their data, without compromising on features, design, or compliance.

Visit our page to learn more.

Since June 2022, SMART-TRIAL is a Greenlight Guru product.

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