Dr. Kivia Pontes de Oliveira describes Regulation (EU) 2017/745 with a special focus on the collection, generation and evaluation of clinical data for medical devices.
This webinar includes a short introduction and general requirements on the regulation and definition of clinical data. She discusses potential routes to perform a clinical evaluation; how to indicate, identify and generate clinical data; and strategical steps to start preparing to become compliant now.
About the presenter: Dr. Kivia Pontes de Oliveira is a Consultant for Clinical Affairs at NSF International. She has several years of professional experience in the fields of medical writing and clinical affairs. In the last year, she has evaluated and prepared clinical data and evaluations following the new clinical requirements for medical devices of Class I to Class III.
For more information, contact her at kdeoliveira@prosystem-nsf.com.
