#61 Software as a Medical Device with Nicola Thorn: Design to documentation, Navigating the complexities of compliance and Generative AI

Nicola Thorn CEO and Founder of Tento+ a company that helps companies generate technical documentation that is audit-ready. Nicola is an expert in technical compliance for medical devices working across FDA, UKCA, and CE market approvals for digital health tech products and completed her PhD in Mathematics at the University of Reading, as well as founding Tento+, Nicola is CEO of AND Technology, an award-winning product development consultancy, she has worked in product development in electronics, software, machine learning and Tech 4 Good for over 10 years. In this episode, we explore the application of generative AI tools in software development, examining their advantages for content creation and emphasizing the crucial need to verify their outputs. We also shed light on the entrepreneurial pursuits of individuals within the NHS, discussing the underlying reasons and the existing programs supporting this transition. Additionally, we delve into the risks associated with retroactively documenting design controls, providing insights into the potential pitfalls of such practices. Timestamps: [00:01:55] Design Controls in Retrospective [00:12:26] Generative AI Tools [00:15:53] Reality of Medical Device regulatory timelines [00:20:26] NHS Clinical Entrepreneurship [00:22:56] Reasons for getting into entrepreneurship [00:25:38] The future of AI in Software Get in touch with Nicola Thorn - https://www.linkedin.com/in/nicola-thorn-725131ab/ https://andtr.com/ https://tentoplus.com/ Get in touch with Karandeep Badwal - https://www.linkedin.com/in/karandeepbadwal/ Follow Karandeep on YouTube - https://www.youtube.com/@KarandeepBadwal Subscribe to the Podcast