Saloni Shah
Compliance Lead & Engineer ResMed
I am a compliance and risk leader with 8+ years of experience working in regulated, high impact systems where trust, safety, and accountability are critical. My work focuses on translating complex regulatory expectations into practical governance and operational controls that enable innovation while effectively managing risk. Across my career, I have led and supported risk management, audits readiness, and compliance strategy for medical devices, Software as a Medical Device (SaMD), and AI enabled, data driven products. I work closely with regulatory, quality, engineering, product, privacy and security teams to ensure governance is embedded into real world delivery not treated as a parallel or post-hoc exercise.
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?
Practical walkthrough of how a team built quality checkpoints into everyday development followed by peer discussion
- Moving from document-heavy compliance to integrated development checkpoints
- Building quality gates into design, development, and release workflows
- Reducing late-stage remediation through earlier risk and requirements control
- Cultural and tooling shifts required for “living” quality systems
