#57 Software Medical Devices with Weronika Michaluk: Agile vs Waterfall Methodologies, SaMD & SiMD and Exploring Complex Fields

Weronika Michaluk Digital Health Principal and SaMD Lead at HTD, a company specialising in the planning, designing and development of custom healthcare software. Weronika is an experienced professional with a diverse background in the fields of biomedical engineering, international business and public health. Her career began as a Biomedical Engineer, where she contributed to the development of various biomedical devices, including a wireless ECG system, then she worked in South Korea in the Neuroscience Department and after that, she focused on digital health solutions and consulting in the medical device space. In this episode, we delve into the world of software medical devices, explore the agile and waterfall approaches in software development and their application to regulated medical devices. We discover the crucial role of software in medical devices, uncover how some companies unintentionally market unregulated medical products and learn how to stay updated with the ever-evolving regulations. Timestamps: [00:00:10] What makes a software a Medical Device [00:05:57] Complexity of regulating software [00:11:52] Agile individuals and interactions over processes [00:17:30] Software medical device: engineering, research, business and coding [00:23:00] How to keep up with regulations Get in touch with Weronika Michaluk - https://www.linkedin.com/in/weronika-michaluk-mba-43811698/ https://htdhealth.com/ Get in touch with Karandeep Badwal - https://www.linkedin.com/in/karandeepbadwal/ Follow Karandeep on YouTube - https://www.youtube.com/@KarandeepBadwal