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A Five Step Approach to Device Risk Management

Companies are faced with challenges to make medical devices safe for human use. Risk management is an integral part of the medical device product development lifecycle. It helps medical device developers ensure that the product is reliable, works as expected and causes no harm to the patients, operators or the environment. In other words, the main purpose of the risk management cycle is to reduce or mitigate the chances of failure in the product. In this session participants will look at a five step approach to risk management. In this interactive session participants will gain knowledge into the identification, assessment, evaluation, reduction, control and monitoring of risk that are essential to device risk management. Speakers will provide tools, guidance, and some tips on developing a risk management strategy.

Speakers:

  • Suheila Abdul-Karrim, CCRA, CCRT, FACRP, CSci, Clinical Research Consultant, Auditor, and Trainer, Independent Consultant

  • Deborah Rosenfelder, BSN, CCRC, FACRP, Clinical Data Scientist, Becton Dickinson