Welcome to the Pacific Design & Manufacturing Presentation Store. Here you can view and download conference and/or show floor theater presentations before, during, and after the event. If you’re looking for a presentation from a specific session that you’re unable to find here, note that it’s likely because the presenter has not provided permission for external use or has not yet shared their presentation with us. Please check back after the event for a more complete catalogue of available presentations.
Bernhard Kappe is CEO of Orthogonal, the leading developer of mobile and cloud applications for medical device and diagnostic companies, with expertise in firmware, mobile apps, AI algorithms and cloud services.
Mr. Kappe is the author of Agile in an FDA Regulated Environment and the upcoming the upcoming Best Practices for Software as a Medical Device and Connected Device Development.
He’s interviewed dozens of practitioners who have received clearance or approval for SaMD and connected devices, and has synthesized this feedback with Orthogonal’s own experience in order to lay out a set of best practices and antipatterns for developing SaMD and Connected Device solutions with AI Algorithms.