# Predetermined Change Control Plan (PCCP) outline

Align sections with your regulator’s guidance (e.g. FDA PCCP for AI-DSFs; Health Canada MLMD PCCP expectations). This is a working draft for internal review with QA/RA.

**Device / software version:**  
**Date:**  
**Authors:**

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## 1. Description of modifications

List specific, bounded changes planned after initial authorization (e.g. retraining within defined data criteria, architecture changes explicitly excluded).

- Modification category A:
- Modification category B:
- Out of scope (requires new submission):

## 2. Modification protocol

For each category, describe how modifications will be developed, verified, validated (as applicable), and released.

- Data acceptance criteria:
- Retraining / fine-tuning procedure:
- Verification and validation activities:
- Labeling and IFU updates:
- Cybersecurity review (SBOM delta, vulnerability assessment):

## 3. Impact assessment

- Benefit–risk discussion for using a PCCP:
- Hazards and risk controls affected (link to ISO 14971 line items):
- Performance envelope / guardrails:
- Post-market monitoring updates tied to this PCCP:

## 4. Traceability

- Requirements / design items updated per release:
- Records location (DMS, ticket IDs):