Davide Mercadante is a medical engineer with 10-plus years of experience within multiple areas of device and combination product development, including design and development, design quality assurance, verification and validation engineering, qual­ity control and supply chain quality. He received his bachelor’s and master’s degrees in medical engineering from the Second University of Rome, where his focus was on medical device design and development. Davide has a Lean Six Sigma Green Belt and he currently works at Biogen in the corporate quality device group where he is the quality project lead for both the risk management continuous improvements and combination product DHF 21 CFR Part 4 final rule enhancement projects. He has also been instrumental with the integration of software as a medical device into the exist­ing quality management system.