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,  Greenlight Guru Clinical 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,
Greenlight Guru Clinical (formerly SMART-TRIAL)

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 connected, cloud-based platform purpose-built for MedTech companies. The end-to-end solution streamlines product development, quality management, and clinical data management by integrating cross-functional teams, processes, and data throughout the entire product lifecycle.

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.


About Greenlight Guru Clinical

Greenlight Guru Clinical is the leading clinical data collection toolbox, purposefully built for MedTech. Collect and manage clinical data in pre and post-market clinical studies, including registries, cohorts, surveys, human factor testing, design validation, and more.

Greenlight Guru Clinical meets the regulatory requirements of the FDA, EU, and most other countries, and ensures compliance out-of-the-box with GCP and ISO 14155:2020.

Visit our homepage to learn more.

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