As she began to plan the project, Maria knew that she had to ensure that the software met the rigorous requirements of the medical device industry. Specifically, she had to comply with the IEC 62304 standard, which defined the lifecycle requirements for the development of medical device software.
Non-serious injury. Requires detailed documentation of design, testing, and risk management.
Configuration identification, change control, and status accounting. Iec 62304 Checklist Xls
Are SOUP items identified with version numbers and manufacturers? Applicability: Classes A, B, C.
This is critical. Hyperlink to the specific QMS document (e.g., Hazard Analysis, SRS, Test Reports) to make audits fast and efficient. Best Practices for Maintaining the Checklist As she began to plan the project, Maria
Confirming that individual code units meet design requirements before integration.
| ID | Clause | Activity / Checklist Item | Guidance Notes | Actionable Output | | :--- | :--- | :--- | :--- | :--- | | Q1 | 4.1 | Has a Software Development Plan (SDP) been established? | Must define the life cycle model, deliverables, and traceability requirements. | SDP Document | | Q2 | 4.1 | Is a risk management process defined? | Must align with ISO 14971. | Risk Management Plan | | Q3 | 4.2 | Have the development standards been defined? | Define coding standards, comments, and naming conventions. | Coding Guidelines Doc | | Q4 | 4.3 | Has the Software Safety Class been determined? | Document the rationale for the classification. | Classification Report | Requires detailed documentation of design, testing, and risk
Requirements must be uniquely identifiable, testable, and traceable to Risk Management (ISO 14971).
The following is an example of what an IEC 62304 checklist XLS might look like:
A truly useful checklist goes beyond a simple list of clauses. It should include: