Establish (A, B, or C) with documented rationale.
For each major deliverable, include specific verification checks. For example, before implementation, verify that all software requirements: Iec 62304 Checklist Xls
| Column A | Column B | Column C | | :--- | :--- | :--- | | | Value | Instructions | | Medical Device Name | [Enter Name] | | | Software Version | [Enter Version] | | | IEC 62304 Class | A, B, or C | Select one | | Safety Classification | `` | Per ISO 14971 | | Document Owner | [Name] | | | Last Review Date | [Date] | | | Status Key | | | | NOT STARTED | Red background | No activity | | IN PROGRESS | Yellow background | Partially complete | | DONE | Green background | Evidence exists | | N/A | Gray background | Not required for this class | Establish (A, B, or C) with documented rationale
Specific to Class B and C; unit-level specs. include specific verification checks. For example
Document functional, performance, and risk-related software requirements. Architecture & Design: