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BIOMEDevice Boston 2019 Schedule Viewer

 

Welcome to the Biomed Boston & ESC Boston 2019 Presentation Store. Here you can view and download conference and/or show floor theater presentations before, during, and after the event. If you’re looking for a presentation from a specific session that you’re unable to find here, note that it’s likely because the presenter has not provided permission for external use or has not yet shared their presentation with us. Please check back after the event for a more complete catalogue of available presentations.

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. Being an auditor for TÜV SÜD provided an excellent platform for building a solid foundation of Quality Management Systems as defined by EN ISO 13485 and the European regulatory processes and documentation requirements. Eri is constantly expanding her knowledge base and now working with a Neurovascular Implant company as the regulatory landscape shifts to accommodate the MDSAP and the new EU MDR/IVDR.

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