Managing Change & Its Impact Across the Medical Device Lifecycle

Change control is more than a quality system requirement, it’s a critical driver of regulatory success, product safety, and commercial scalability.

In this 60-minute webinar, experts from QuickVault by Veeva and Rook Quality Systems (RQS) will explore how medical device companies can effectively manage change control across the product lifecycle — from design and development through post-market operations.

The session will cover how regulatory expectations influence change decisions, when changes require new submissions or notifications, and how design, process, software, labeling, and packaging changes can cascade into device function and patient safety. You’ll also hear real-world examples of managing post-market changes driven by customer complaints, along with practical tips for handling technical changes without disrupting timelines or resources.

The webinar will conclude with a live demonstration of QuickVault’s Change Management module, showing how modern eQMS tools can streamline change control while maintaining full traceability and audit readiness.

What You’ll Learn:

• How to assess the regulatory impact of design and process changes
• When changes trigger submissions, notifications, or revalidation
• How to avoid “stealth changes” that lead to compliance risk
• Best practices for maintaining traceability across requirements, risk, and verification
• How digital change management tools support scalable growth

This webinar is ideal for medical device professionals involved in quality, regulatory, R&D, product development, manufacturing, and operations as well as leaders responsible for managing change across pre- and post-commercial stages.