The very thing that many blame for slowing down the whole time-to-market process—regulatory approval—could actually be a good thing, writes Claire McKenna in the April issue of Medical Design.

As the Medical Device Program Manager at the National Standards Authority  of Ireland (NSAI) in Dublin, McKenna has extensive experience with helping clients obtain CE marks for their medical devices so they can sell them in Europe. Requirements for getting FDA approval can be similar. While gaining a CE mark doesn’t automatically mean you can get approval by the FDA - or vice-versa - the data and information used to get either approval will often be the same, she says  excellent roadmap for how companies can work with Notified Bodies to get products approved. She also offers tips for speeding up the CE mark approval process as well as almost any other regulatory approval process.