Biomedevice Boston 2020 Presentation Store
Welcome to the Biomedevice Boston Presentation Store. Here you can view and download conference presentations before, during, and after the event, as well as free content from the Center Stage. If you’re looking for a presentation from a specific session, go to that session, and if we have the presentation to share, you’ll see the file below the session description. If you are unable to find it here, 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.
Exploring the Intended Use Statement's Impact on Regulatory and Marketing Strategies
Eri Hirumi (Regulatory Affairs Specialist, Microvention)
Date: Thursday, May 7
Time: 2:30pm - 4:00pm
Track: Track C: Surviving the Changing Regulatory Environment & Rising Costs
Vault Recording: TBD
The Intended Use statement for any medical device product is the foundation for getting the product successfully to market. It will impact your regulatory and marketing strategies, establish your product risk classifications and mold the product validation plans. Attending this program will provide insight for how a single word in the Intended Use statement can impact how quickly you can obtain Pre-market approvals in the global markets, how you can craft your marketing strategies to meet your business demands and moderate your product validation plans.