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Posted by on in Regulatory and Clinical Strategy

Airo Mobile Intraoperative CT

A Regulatory Strategic Plan (RSP) used to bring a medical product to market requires solid regulatory knowledge married with scientific/engineering/clinical expertise using critical thinking skills.  An RSP does not focus solely on the path to obtain regulatory approval or clearance but also links the approval/clearance to how the product is manufactured, promoted and how future product revisions or line extensions are introduced to the market.  If done properly and maintained over the course of a medical product’s lifecycle a company will have a more predictable product development timeline that can be adjusted as new information becomes available and a product regulatory risk profile that can be actively managed during post market release.  If implemented effectively, the RSP will result in improved operational process efficiency, reduced operational costs, and a reduction in time to market.  If the results of product development or the experience after commercialization is not as predicted, the RSP will better position you to make adjustments and, unfortunately, make the difficult decision to cancel a development project or recall/remove a product from the market.   

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