Our human factors engineers relentlessly focus on designing intuitive software for users; this is the key to helping our clients capture market share while mitigating risk. Our research-driven human factors processes ensure we develop software that is intuitive, that minimizes patient risk and that above all, encourages widespread adoption by patients and clinicians alike.
Our software engineers use Agile and Lean software development processes to quickly develop usable software within 90-days. Our iterative development process is designed to discover problems early and prioritize the elimination of hazards and risk. This streamlined development process accelerates our client’s medical device commercialization efforts.
We support clients through the entire product life cycle. We know that companion software requires, continuing FDA compliance and robust security and technical updates. From post-delivery maintenance to the development of future releases, our in-house software and human factors engineers remain available to clients while the device is on the market.
Our internal quality management system (QMS) is compliant with FDA and EU medical device regulations and ISO 13485 and IEC 62304 standards. This enables us to use design and Agile practices that address the complexity and rapid change inherent in connected care systems. Before the design transfer, we advise and support clients in setting up their internal QMS.
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 medical device software project.