Project information

Project information
Name

First NameLast Name
Email
example@example.com
Business Name
Your Website
1 of 10: Client & Project Basics
Organisation Type
Contact Role
Project Name/Internal Code
Short Description of Device
Device Category
Target Clinical Area
2 of 10: Development Stage
Current Development Stage
How would you describe overall project maturity?
3 of 10: Regulatory & Market Intent
Intended Market
Expected Regulatory Pathway
Has a regulatory strategy been defined?
4 of 10: Design & Technical Status
Design Controls Status
Key Design Outputs Status. Please tick if complete
Prototyping Status. Please tick most appropriate
Manufacturing Process Status (equipment/tooling/etc.)
5 of 10: Quality & Risk Readiness
Risk Management Status (ISO 14971)
Quality Management System
Known Technical or Regulatory Risks
6 of 10: Testing, V&V & Evidence
Verification Testing Status
Validation Activities
Standards Already Identified
7 of 10: Project Goals & Success Criteria
Primary Goal for Engaging Luath Medical
Top 3 project Priorities (next 6 months)
Definition of Project Success
8 of 10: Timeline & Critical Milestones
Next Critical Milestone
Target Date for this Milestone
Is this milestone externally driven?
9 of 10: Engagement Preferences
Type of Support Required
Preferred Engagement Model
Expected Level of Involvement
10 of 10: Readiness & Constraints
Key Constraints
Internal Engineering Resources
- Should be Empty: