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Exploring the Intended Use Statement's Impact on Regulatory and Marketing Strategies

Eri Hirumi  (Regulatory Affairs Specialist, Microvention)

Location: 160A

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.