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.

The Essentials of Medical Device Product Life Cycle Management


Eri Hirumi (Regulatory Affairs Specialist, MicroVention)

Location: 160 B

Date: Wednesday, April 18

Time: 2:45pm - 4:00pm

Pass Type: Conference (Paid) - Get your pass now!

Conference Track: Biomed Track B: Product Development

Vault Recording: TBD

Design and development engineers make significant decisions throughout a medical device product life cycle. These decisions may impact not only the cost of a product, but also the product function and quality. Moreover, regulations are constantly changing to capture and control these linkages. This session will explore how to balance these often-conflicting requirements.

Topics covered will include:
  • How decisions made by development engineers at all stages of a product life cycle may impact product performance
  • Ways regulatory agencies are adapting their requirements to ensure consistent controls for safe and effective medical devices
  • Strategies you can use to help product development engineers and regulatory teams get faster global approvals