Capability Pattern: Process Guidance Evaluation
This scenario provides a roadmap to reviewing the process assets that are part of the Medical Devices Solution. Click the items in the diagram or in the corresponding items in the Work Breakdown structure to navigate to the detailed guidance.
Work Breakdown Structure
Workflow

Activity diagram: Process Guidance Evaluation Understand the Process Concepts Study the Content Layout Study the RTC/RMC Integration Review the Design Control Objectives Review the IEC 62304 Mapping Provide Feedback on Process Content Review the IUV Content Study the DOORS Process Integration
Work Breakdown