Stage 04 of 12
Development planning
Align the regulatory path, quality system, resources, and development plan.
Entry criteria
- Feasibility supports continued investment
- A preferred architecture exists
- Target markets and launch assumptions are identified
Required activities
- Define the regulatory strategy and standards plan
- Establish design-control and risk-management procedures
- Build the integrated schedule, budget, and responsibility matrix
- Plan supplier, verification, validation, and clinical activities
Expected deliverables
- Design and development plan
- Regulatory strategy
- Quality and risk-management plan
- Resource, schedule, and budget baseline
Recommended capabilities
Look for providers with relevant device, market, and stage experience—not capability labels alone.
Common risks
- Regulatory evidence added after design decisions
- Underestimating external laboratory lead times
- Unclear ownership across startup and provider teams
Exit criteria
- Scope, milestones, owners, and decision gates are approved
- Regulatory and quality strategies are integrated
- Critical external partners and long-lead work are identified
Suggested next actions
- Baseline detailed design inputs
- Select development and manufacturing partners
- Begin formal design reviews
Find your next move
Build confidence in development planning.
Map your current evidence and gaps to the capabilities needed for this stage.