1. Project Overview
Project Name
Project Lead
Department/Team
Project Start Date
Background
Objectives
2. Stakeholders & Key Contacts
Internal Stakeholders
External Stakeholders
3. Device Description
Device Name
Intended Use/Indications
Overview of Principle of Operation
Proposed Target Users
Key Features
4. Regulatory Pathway
Target Market(s)
Expected Device Classification
Relevant Regulatory Standards
Certification Requirements
5. Project Milestones
Key Milestones & Timeline
6. Resources & Budget
Key Resources Needed
Estimated Budget
7. Risks & Challenges
Key Risks
Risk Mitigation Strategies