GenAI-Powered Quality and Compliance Innovation: Bridging Product Design with Regulatory Standards Across Cloud Enterprise and Distributed IoT Ecosystems

Session Abstract:

In the session, “GenAI-Powered Quality and Compliance Innovation: Bridging Product Design with Regulatory Standards Across Cloud Enterprise and Distributed IoT Ecosystems,” we’ll introduce a transformative approach to aligning project requirements with regulatory standards across complex ecosystems. From defining project requirements to mapping them to regulatory documentation across both internal and external repositories, this session will illustrate how to gather critical data, contextualize it, and identify areas where product development practices may need improvement. Attendees will learn strategies for pinpointing issues within test cases, code, and project communications, enabling proactive quality and compliance management. We’ll discuss how these insights can enhance agile workflows, showing ways for Scrum teams to seamlessly incorporate regulatory and quality checkpoints. Imagine your quality team gaining real-time visibility into compliance gaps. Envision the agility of a fully integrated system that swiftly adapts to changes, ensuring both speed and compliance.

Speaker:

With more than 30 years of product development experience across various industries, David Rowe has held key roles, including Lead Architect, Lead Developer, Data Engineer, Program Manager, and Product Manager. He has led critical engagements in medical device technologies, focusing on engineering and FDA compliance, as well as in digital health solutions, from initial concept to HIPAA compliance. David’s expertise spans application architecture, development, and device integration, randing from wearables to implanted devices and Lean optimization in surgical supply chains. His background also encompasses machine learning model development and IoT solutions integration across multiple industries.
Currently, as EVP for Healthcare and Life Sciences at Intellias, David drives initiatives in engineering, quality, and regulatory compliance innovation.