Clinical Investigation Plan (CIP)

A Clinical Investigation Plan (CIP) is any systematic investigation of a medical device that involves one or more human subjects. The CIP describes the rationale, objectives, design methodology, monitoring, conduct, record-keeping and the method of analysis for a clinical investigation. Requirements for the CIP are detailed in Annex XV (Chapter II, Section 3) of the Medical Devices Regulation (2017/745).

 

Contact us

Fill out the form below to request more information.

 

Customer testimonial:

 

“I can really trust the Emtex writers to deliver a quality document on time, to reach out to me or team members when appropriate, and to adapt to our changes in process/template over time. The consistent quality of work– and that this is true of all the writers. The willingness and ability to learn and improve. The good balance between independent work and reaching out to me or the team when appropriate. The effective and friendly communication.”

Senior Medical Writing Leader

This website uses (anonymous) analytical cookies.

More info