PCCP Checklist for Medical Device Companies

Pre-determined Change Control Plan

The PCCP Checklist serves as a structured guide for medical device companies to develop, implement, and maintain a Pre-determined Change Control Plan (PCCP) in compliance with FDA guidelines. This checklist was developed by Rook Quality Systems in partnership with Greenlight Guru.

This tool is designed for:

• Traditional medical devices (e.g., hardware-based medical devices, implantable medical technologies)
• Artificial Intelligence-Enabled Device Software Functions (e.g., AI diagnostic systems, imaging analysis software)
• Devices involving software, hardware, labeling, and manufacturing process changes

This tool helps organizations:

• Identify and categorize foreseeable device changes
• Align with FDA’s PCCP requirements and regulatory expectations
• Integrate risk management, validation, and implementation workflows
• Streamline regulatory submissions and post-market monitoring

This checklist provides a practical tool for teams to navigate change control effectively, reducing regulatory burdens while maintaining device safety and effectiveness.

Key Features of PCCP Checklist

• Regulatory Alignment – Ensures compliance with FDA PCCP guidelines.
• Regulatory References – Easily gain more information on the FDA’s expectations for each PCCP task in the checklist by clicking the embedded link(s) in the correlating row.
• Workflow & Approval Mechanisms – Provides a step-by-step process for reviewing and approving changes within a quality management system (QMS).
• Post-Market Monitoring – Includes guidelines for tracking changes, performance monitoring, and regulatory reporting post-implementation.
• Cross-Functional Collaboration – Assigns responsibilities to Regulatory, Quality, R&D, and Risk Management teams for effective execution.
• Customizable & Scalable – Adaptable to various medical devices, software functions, and manufacturing processes.