Maria Donawa authors new White Paper for BSI Compliance Navigator

Donawa Lifescience President, Maria E. Donawa M.D., has authored a new White Paper for inclusion in BSI’s Compliance Navigator series, titled ‘Medical device clinical investigations – What’s new under the MDR?’

The 30 page document discusses the important new requirements for pre-market and post-market clinical investigations included in the European Medical Device Regulation (MDR, 2017/745), while addressing the importance of defining the regulatory purpose of a study, the relationship of a clinical investigation with quality management system (QMS) practices, and strategies for conducting a successful clinical investigation.

Copies of the White Paper can be accessed from the BSI website (sign-in required).

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