Phase-Appropriate Design Controls for Novel Devices in Clinical Trials
Thu, Oct 29
|
04:30 PM - 04:45 PM
Independence
Session details:
Novel drug-device combination products face a common tension: applying full design control rigor too early slows innovation, while under-scoping it invites costly rework and regulatory risk later. This session offers a practical high-level framework for right-sizing design controls to match each stage of clinical development.
Attendees will leave with:
- A phase-based model for scaling design control activities from early feasibility through pivotal and commercial readiness
- Common pitfalls that trigger late-stage rework or FDA questions
- Practical alignment with human factors and ISO 14971 risk management as devices mature
