The Association of Clinical Research Professionals

Webinar Update

An open-access recording of the webinar, Crack the Code: A Comparison of ICH E6(R2) and ICH E6(R3), is available in our Guidelines and Regulations Resource Center.

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ISO 14155 and FDA Requirements – Trials Conducted at the Research Site

This program explored medical devices and investigational medical devices.

The presenter provided information on FDA regulations and ISO requirements along with the similarities and differences for device trials conducted at the research site.

Upon completion of this continuing education program, participants should be able to:

  • Define what is considered a medical device.
  • Define and provide examples of an investigational medical device.
  • FDA regulations and ISO requirements for device trials conducted at the research site.

Speaker:

Pranali Wandile, MS, CCRP, Clinical Research Manager, South Carolina Clinical Research LLC

Approved for 1.0 ACRP Contact Hours | Expires  December 5, 2026