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.
Lightening Workshop: Exploring the Intended Use Statement's Impact on Regulatory and Marketing Strategies
Eri Hirumi (Regulatory Affairs Specialist, Microvention)
Location: Biomed Room 1
Date: Thursday, September 17
Time: 3:00 pm - 4:30 pm
Track: Track C: Surviving the Changing Regulatory Environment & Rising Costs
Vault Recording: TBD
- Explore impacts of the intended use statement on reimbursement, regulatory and market strategy, including label design
- Discuss product and process validation plans
- Provide opportunities to practice developing intended use statements to understand the impacts upon getting products to market