Abhineet Johri
Regulatory Affairs Quality Assuarance Professional Siemens Healthcare Diagnostics
Abhineet Johri is a RAQA professional at Siemens Healthineers, specializing in regulatory compliance and quality assurance for advanced healthcare technologies. Based in Malvern, Pennsylvania, he supports innovation by ensuring products meet rigorous global standards for safety, performance, and reliability.
Seminars
A practical, end-to-end walkthrough of how regulated medical device software is actually built, controlled, and monitored in the real world. Participants will move chronologically through the product lifecycle, connecting design controls, risk management, and post-market activities into one continuous system
- Walk through the full software lifecycle, from intended use and design controls to risk management, V&V, change control, and post market surveillances show how each stage connects and shapes regulatory expectations
- Use hands-on exercises and scenario-based discussions to practice drafting design inputs, risk tables, and change assessments while exploring how AI, automation, and real-world data influence control strategies
- Give attendees a clear mental model of an end-to-end lifecycle, practical examples of strong documentation and traceability, and confidence in building processes where quality and compliance are integrated throughout development
- Extend these principles to ML/AI-enabled devices, demonstrating how design controls, risk management, validation, monitoring, and change management are adapted for adaptive algorithms and continuously learning systems
Closing Question: How do you apply design controls & do you even apply design controls to non-medical device software?
- Understand how FDA, EU MDR, and the EU AI Act expectations intersect
- Learn where global evidence can be reused versus duplicated
- Explore traceability and UDI expectations for software
- Leave with a more efficient global submission strategy
