Stage 05 of 12
Detailed design
Develop controlled hardware, software, mechanical, and optical designs.
Entry criteria
- Design inputs and development plan are approved
- System architecture and interfaces are defined
- Design-control procedures are operating
Required activities
- Develop subsystem designs and interface specifications
- Implement software lifecycle and cybersecurity controls
- Update risk controls and traceability
- Conduct formal design and manufacturability reviews
Expected deliverables
- Controlled drawings and specifications
- Software architecture and source baseline
- Bill of materials
- Updated traceability and risk files
Recommended capabilities
Look for providers with relevant device, market, and stage experience—not capability labels alone.
Common risks
- Subsystem optimization that breaks system performance
- Late cybersecurity or usability requirements
- Uncontrolled parts and design-output changes
Exit criteria
- Design outputs are complete enough to build representative units
- Reviews close critical interface and risk issues
- Prototype configuration is controlled
Suggested next actions
- Build representative alpha and beta units
- Confirm prototype inspection criteria
- Prepare verification method development
Find your next move
Build confidence in detailed design.
Map your current evidence and gaps to the capabilities needed for this stage.