9/13/2020

When: September 17, 2020

Time: Live from 1-2 PM EDT

Register: HERE

Released in July 2020, ISO 14155:2020 is the third version of the standards that provides direction on how to implement GCP for medical device clinical investigations. The changes in this revision are designed to ensure that ISO standards are up to date with regulatory changes in the industry including the European Union’s (EU’s) Medical Device Regulation (MDR): EU 2017/745 and the Food and Drug Administration’s (FDA’s) guidance, “Medical Device Reporting for Manufacturers.” Some of the main changes in ISO 14155:2020 include:

A summary section of GCP principles
Guidance on risk-based monitoring
Guidance on clinical quality management
Guidance on clinical investigation audits

Since its release, ISO 14155:2020 has now replaced the previous version, ISO 14155:2011.

Join Sandra “SAM” Sather during this interactive live session to learn about these changes and compare the 2020 and 2011 standards to assist with gap analysis, process improvement, and updates to your clinical trial quality systems and training programs.

-The Clinical Pathways Team

Enjoy this blog? Please like, comment, and share with your contacts.