Weronika Michaluk on Medical Devices development
Weronika Michaluk, Software as a Medical Device Practice Lead at HTD Health, explains how her company bridges firmware and software teams through shared backlogs, daily stand-ups, and mutual technical leads. She details the implementation of a compliant agile process that integrates tools like Jira, GitHub, and Greenlight Guru to manage requirements and version control without sacrificing regulatory compliance. Michaluk highlights the importance of aligning on versioning schemes and documentation standards to prevent bottlenecks and ensure that change orders are efficient rather than just bureaucratic friction. The conversation also covers the evolving understanding of agile methodologies among medical device clients, ranging from technical startups to non-technical founders.