Healthtech Stage: Navigating the regulatory process
The range of talks at Med-Tech Innovation Expo means that there is something everyone. Whether you’re a manufacturer, a company representative or simply an interested visitor, Med-Tech Innovation Expo has something for you.
The use of software within medtech is rapidly changing the regulatory landscape.
Launching a medtech product within the US often depends on successfully navigating FDA software strategies.
On day one of Med-Tech Innovation Expo, Ken Block, president and founder of Ken block Consulting will discuss recent drafts and final FDA guidance on a variety of topics.
The session will focus on areas including, clinical evaluation for software as a medical device, interoperability and clinical/patient decision software.
The talk will also discuss the changes to FDA software policies prompted by the recent 21st Century Cures Act, as well as the new FDA Software Precertification Program.