John Schalago MSc

John is a Regulatory/Quality/Clinical professional with over 30 years of experience in research & development, quality assurance/control, clinical affairs, regulatory affairs, and executive management. John has extensive experience with global health authorities as well as with CDRH, CBER, and CDER managing submission strategies, HA interactions, and submissions. John has a diverse background which includes expertise in combination products, software-controlled medical device submissions including, sensors (implantable, minimally invasive, and in-vitro diagnostics, and software as a medical device, including, mobile applications and web-based clinical decision software.