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White Paper


A Review of Regulatory Changes around the Globe

Since 2013, there has been a flood of changes to Medical Device regulations around the world. Many countries are attempting to modernize their regulatory controls over Medical Devices to allow for increased patient safety and greater access to medical devices. Staying abreast…

White Paper


Pathways for IDE Approval: Which Best Fits Your Needs?

There are several options for sponsors who are seeking IDE approval or FDA feedback regarding an IDE. Each option offers different benefits, depending on what type of trial the sponsor is seeking to initiate and how much time the sponsor is looking…

BBA News and Blog

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