In the development of Software as a Medical Device (SaMD), there’s often a tension between moving at the speed of Agile and adhering to a Quality Management System that is document-based, which can be tedious to maintain.
An electronic Quality Management System (or eQMS), like the one recently deployed internally by Orthogonal, keeps up with the pace of Agile SaMD development by plugging directly into the tools that development teams already use for their work. This data-driven, automated approach to eQMS can give your organization a huge competitive advantage, enabling the production of a continuous stream of successful devices that improve the health and quality of peoples’ lives faster.
Join us on September 29, 2022 for a webinar featuring a live demonstration of Orthogonal’s Agile eQMS, as part of our Move Faster and Break Nothing Webinar Series. Tune in from 12-12:45 PM CST to learn about the latest in best practices for Agile SaMD development under a modern eQMS.
Bernhard Kappe, Orthogonal CEO and Founder
Bernhard is a software development leader, technologist, and pioneer who provides clients with an unequaled advantage by helping them develop Software as a Medical Device (SaMD), Digital Therapeutics (DTx), and connected medical devices, while leveraging important trends and techniques at the leading edge of the adoption bell curve (e.g., agile software development, lean user experience, software product management, DevOps, lean startup, and open-source software). Bernhard has exclusively focused on the medical device and health-tech industry for almost a decade, working with clients to create innovative diagnostics, monitoring, and therapeutics solutions, while shortening product development life cycles, improving delivery predictability, and creating products that are financially and clinically successful.
Melissa Gill, Principal Product Owner
Melissa has 10 years of experience in Agile Project/Product Management and four years of experience in QA. She has worked in enterprise, security, pharma and SaMD industries on web, mobile and cross-platform projects. Melissa brings her experience implementing Jira/Confluence and Agile processes at various organizations to Orthogonal, where she also implements eQMS tooling and process improvements.
Randy Horton, Chief Solutions Officer
Randy has spent over a decade working with healthcare and life sciences organizations to tackle the Quadruple Aim: 1) optimizing health system performance by improving the individual experience of care, 2) advancing the health of populations, 3) reducing the per capita cost of care, and 4) enhancing the work-life of those who deliver care. Randy brings strong experience, expertise, and creative business thinking to his leadership role – along with nearly three decades of experience with Internet-enabled digital transformation and a passion for being a connector of people and ideas. He helps organizations break through to their “what’s next” by building new capabilities and launching innovative, digitally enabled – and highly successful – products and services.
Orthogonal continues to host events and conversations aimed at improving patient outcomes and driving business results. Keep up with the schedule of events throughout the rest of the year by signing up for our mailing list.