Preparing for Your IVDR Data Hunt: An ISC22 Conversation

Описание к видео Preparing for Your IVDR Data Hunt: An ISC22 Conversation

Designers of medical devices scrambling to determine how they may navigate the requirements of the EU's new In Vitro Diagnostics Regulation (IVDR).

During the 2022 AAMI/FDA/BSI International Conference on Medical Device Standards and Regulation, Sarah Chavez, director of IVD & Scientific Writing Services for Criterion Edge, sat down with AAMI’s Robert Burroughs, chief learning and development officer, and Joe Lewelling, senior advisor for industry, to discuss the art of collecting suitable real-world data about a medical device in order to meet EU requirements.

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