Michael Iglesias
Digital Health Engineering & Quality Professional Merck & Co
Michael Iglesias is a Digital Health Engineering and Quality leader at Merck, specializing in Quality Systems and the Software Development Life Cycle for health technologies. His expertise spans eQMS, Health AI, Clinical Decision Support, Digital Twins, SaMD, and SiMD, driving compliant, scalable digital innovation across regulated healthcare environments.
Seminars
- Explore using AI for code generation, unit tests, peer review, and documentation drafting
- Identify hidden risks: hallucinated logic, unverifiable outputs, and traceability gaps
- Learn Verification strategies when AI contributes to regulated development artifacts
- Defining where human oversight and accountability must remain in AI-assisted workflows
This dynamic fishbowl debate brings engineers, clinicians, and regulatory leaders into a rotating inner‑circle conversation, creating a rare, real‑time exchange between those designing AI systems, those deploying them, and those overseeing their safety. With audience members stepping into the discussion throughout, the session becomes a living model of the very human‑machine interaction it examines.
- Discuss how assistive, decision‑support, and autonomous AI shift risk, validation, and oversight, enabling attendees to match autonomy levels to the appropriate regulatory and safety strategy
- Examine where AI improves consistency and where it introduces over‑reliance or hidden errors, giving participants clearer judgment on when human review adds safety value
- Explore how claims, labelling, and clinical context constrain autonomy, helping attendees align design decisions with regulatory positioning
- Break down models for “human in the loop,” “on the loop,” and supervisory control guiding teams to design workflows, interfaces, and monitoring that meet regulator and clinician expectations
