AIa-CMP

Change Description

Complete the structured change description. The Change Agent will apply the AI-Agentic Change Management Process v4.0 framework and produce a draft assessment for human review.

Device Identification

Device Name

AI Model Type

IEC 62304 Software Class

Deployment Context

Intended Use (current approved)

Regulatory Classification

Change Description

Change Type

Change Trigger

Change Description (plain language)

Affected Components (software items, models, datasets)

Territory Scope

EU US UK

EU Regulatory Note: EU MDR 2017/745 applies now. The EU AI Act 2024/1689 creates additional obligations for AI systems but does not apply in isolation to medical devices — MDR remains the primary framework. Implementing acts supplementing MDR for AI-enabled devices (SaMD) are expected in force 2027; for embedded AI devices (SiMD) 2028. Sections touching the EU AI Act are flagged as REGULATORY_UNCERTAINTY during this transitional period.

Key Flags

PCCP in scope PCCP boundary triggered IU affected Risk reassessment required

Additional Context (optional)

Time estimate: A full 35-section assessment takes approximately 15–20 minutes to generate. You can switch to another tab or application while it runs — you will receive a browser notification when it is complete.

Human Review Interface

Review each agent-drafted section. Approve, Modify, Reject, or mark Not Applicable. All actions are logged.

✓ 0 Approved ✎ 0 Modified ✗ 0 Rejected N/A 0 ⏳ 0 Pending

Required Actions

Specific activities identified during assessment that must be completed before this change may be implemented. Routine review is not listed here — only genuine new activities triggered by this change.

Required before implementation: The following activities were identified as genuinely necessary as a result of this change. Routine review activities are not listed. Each item must be completed and evidenced before the change may be implemented and released.

How would you like to proceed?

Continue with the in-app approval workflow, or transfer this record to your eQMS now.

Change Execution

Assign a Change Owner responsible for driving execution of this change. Once all required actions are complete, confirm execution below.

Change Owner Details

Full Name

Title / Role

Email (for future notification)

Date of Confirmation

I confirm that this change has been executed as planned and that all required actions identified in the assessment have been completed and appropriately evidenced in the change record.

Printed signature block (appears on exported report)
Name: _________________________________ Title: _________________________________
Signature: _________________________________ Date: _________________________________

Final Approval

Regulatory sign-off confirming this change record is complete and accurate. The final signature is 21 CFR Part 11 compliant for printed records.

Approver Details

Full Name

Title / Role

Email (for future notification)

Date of Approval

Meaning of Signature

21 CFR Part 11 Declaration: By signing this record, the approver confirms that: (1) this record accurately reflects the change assessment process conducted; (2) the approver has reviewed and is satisfied with the completeness of this change record; (3) this signature constitutes the legally binding equivalent of a handwritten signature for the purpose of this change management record under 21 CFR Part 11.

I have read and understood the above declaration and confirm my approval of this change record.

Printed signature block — 21 CFR Part 11 (appears on exported report)
Name: _________________________________ Title: _________________________________
Meaning of Signature: _________________________________
Signature: _________________________________ Date: _________________________________

Export & Submit

Export the completed assessment for regulatory submission, QMS upload, or eQMS import.

PDF Document

Formatted assessment report with implementation actions — suitable for QMS upload, regulatory submission, or printed records.

JSON for eQMS

Machine-readable structured export including all 35 sections, regulatory references, implementation actions, and audit trail — for eQMS import.

Supporting QMS Documents

Download the AIa-CMP Standard Operating Procedure and Work Instruction for integration into your Quality Management System.

AIa-CMP-SOP-001

Standard Operating Procedure — regulatory framework, compliance mapping, roles and responsibilities.

AIa-CMP-WI-001

Work Instruction — step-by-step guidance for using the AIa-CMP tool within your QMS.

Audit Log

Timestamped record of all Change Agent and reviewer actions. This constitutes the ISO 13485-compliant accountability record for this agent-assisted change assessment.