TMP-C-005 Project Plan

Rev A
Rev Descriptio Reason for Revision Effective Change
n of Change Author Date Number
Change
A Initial To support Andrew 08/18/2015 CN-1004
Release Design Rynearson
Control
requirements
 TMP-C-005 Rev. A
Project Plan Effective Date: 08/18/2015

Project Plan
Document Number:
Project Description:
Date:
Responsibility Matrix Product Development Team

Quality/Regulatory
Key

Director/General
MM Team

Project Leader
R = Responsibility (Drafts and Approves)

Independent

Planed Date
Reviewer

Actual Date
A= Approve (Approves Deliverable)

Manager
I= Inform (Copied on Deliverable)
Note: Template is only a guideline and may be Team members MUST
modified as appropriate. approve assigned
responsibility by

Name
Minimum Approvals are dictated by WI-C-008 adding their initials

Phase 1: Design Preparation

Executed Contract OR Approved New Project Proposal Or Significant Product
Modification
Project Plan
Product Specification
Risk Analysis
Intellectual Property Review Summary
Regulatory Review Summary
Benchmarking Summary
Clinical Immersion Summary (optional)
Literature Review Summary (optional)
Market Research Summary (optional)
Risk Management
Phase 1 Phase Review
Phase 2: Design Qualification
Project Plan
Qualification Test Summary
Project Log
Risk Analysis
Tolerance Analysis
Product Specification
Design Documentation
Technical Review
Risk Management
Phase 2 Phase Review
Phase 3: Design Verification
Product Specification
Risk Analysis
Verification Protocols & Reports
Project Log
Technical Review
Risk Management
Phase 3 Phase Review
Phase 4: Design Transfer
Pre-Design Transfer Assessment
Process Validation Protocols & Reports
Device Master Records (DMR)
Regulatory Submissions
Risk Management, PFMEA
Phase 4 Phase Review

CN-1004 Page 2 of 3
 TMP-C-005 Rev. A
Project Plan Effective Date: 08/18/2015

Phase 5: Design Validation

Project Plan
Product Specification
Risk Analysis
Design Validation Protocols & Reports
Labeling Review
Technical Review
Regulatory Approval
Essential Requirements Checklist (Europe)
Technical File / Design Dossier (Europe)
Human Clinical or Market Testing Protocol
Human Clinical or Market Testing Report
Post Market Surveillance Report (US)
European Vigilance Report (Europe)
Phase 5 Phase Review

Approvals
Modal Manufacturing
Title Name Signature/Date
Project Leader

Quality /Regulatory

Director/General Manager

Independent Reviewer

CN-1004 Page 3 of 3