We begin every medical software development project with an intense period of data collection and formative assessments called an Inception.
The Inception is a collaborative in-person workshop designed to explore and capture the system’s functionality and intended users. Our subject matter experts in human factors engineering, Agile development and Quality Systems collaborate with project stakeholders to identify and define work flows, user types, functionality, risks and everything else necessary to facilitate the start of a successful and detailed design, development and FDA submission effort.
At Orthogonal, every project begins with an Inception. Contact us to learn more or to schedule an Inception for your Software as a Medical Device (SaMD) project.