| Process | Class A | Class B | Class C | | :--- | :--- | :--- | :--- | | | Required | Required | Required | | Requirements | Required | Required | Required | | Architecture (HLD) | Recommended | Required | Required | | Detailed Design (LLD) | Not required | Not required (but typical) | Required | | Unit Verification | Not required | Not required | Required | | Integration & System Test | Required | Required | Required | | Risk Management (SOUP) | Required | Required | Required |
Latest Version Pdf — Iec 62304
| Process | Class A | Class B | Class C | | :--- | :--- | :--- | :--- | | | Required | Required | Required | | Requirements | Required | Required | Required | | Architecture (HLD) | Recommended | Required | Required | | Detailed Design (LLD) | Not required | Not required (but typical) | Required | | Unit Verification | Not required | Not required | Required | | Integration & System Test | Required | Required | Required | | Risk Management (SOUP) | Required | Required | Required |