By Minh Han, MD, FAAFP, Nerac Analyst
Originally published June 24, 2019
On the weekend of April 26, 2019, the Marvel Cinematic Universe (MCU) released Avengers: Endgame, which became the highest grossing movie in an opening weekend ($357M in the U.S., $1.22B worldwide) and highest grossing movie of all time. What made the movie such a box office and critical success was that Avengers: Endgame was the culmination of a story arc that spanned 22 movies over 11 years.
In the same way that the MCU planned and storyboarded their movies, the Clinical Evaluation Plan (CEP) of the Medical Device Regulation 2017/745 (MDR)1 is designed to do the same. The CEP builds a “storyboard” that explains how that device will meet the need and lays out a plan to show it.
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