April 18–19, 2018Boston Convention & Exhibition CenterBoston, MA

BIOMEDevice Boston 2018 Schedule Viewer

View, browse, and sort the education offerings, networking opportunities, and event activities by using the filters below; you can search by Pass Type, Free Content & Activities, and Conference Track. With this session scheduler, you can build your daily agenda in advance and access the full list of options during the event. Sessions do fill up and seating is first come/first serve, so please arrive early to sessions that you would like to attend.

Eri HirumiRegulatory Affairs SpecialistMicroVention

Eri started her career as a Development Chemist for a very small electrophoresis product line that provided training on a broad spectrum of skills on the complete product life cycle. This training highlighted the key importance of managing documentation. The growing labeling knowledge sparked her interest in other parts of regulatory. Working on the labeling requirements led to an opportunity to lead the Technical publications group in Brea. This in turn developed a detailed knowledge of world-wide IVD labeling requirements and the interplay with different standards. Eri shifted her career to into Regulatory Affairs. She continues to expand her knowledge on global regulatory requirements. Different requirements such as chemical hazard communication, global registrations, import/export requirements, biological origin permitting and country of origin marking requirement were all interwoven into supporting a complete product life-cycle. Reinforcement of EU regulations were acquired by being an auditor for TUV SUD. The journey to acquire regulatory knowledge continues with MicroVention and working on their neurovascular medical devices.

Presenting: