Executive Brief: PCCPs as a Competitive Strategy

Let's Talk Risk! Podcast · Oct 23, 2026 · 20m · transcript

PCCPs can turn regulatory cycle time into a competitive advantage, but only if the evidence needed to support future change is funded in advance.

Predetermined Change Control Plans (PCCP) are often discussed as a regulatory mechanism for managing future device modifications—particularly for AI-enabled medical devices.

But their strategic significance goes considerably further.

A well-designed PCCP allows a manufacturer to establish in advance what may change, how those changes will be evaluated, and what evidence will be required before implementation. That can fundamentally change how…