: Offers a free IEC 62304 Requirement Mapping template that maps standard clauses to specific quality management system (QMS) documents. They also provide a Software Release Checklist which can be used as a "bare minimum" compliance tool.
| Requirement ID | Source | Design Component | Test Case | Status | |----------------|--------|------------------|-----------|--------| | SWR-01 | User need | Module A | TC-01, TC-02 | Pass | | SWR-02 | Risk analysis | Module B | TC-03 | Pass | | ... | ... | ... | ... | ... | Iec 62304 Checklist Xls
IEC 62304 is an international standard for medical device software, published by the International Electrotechnical Commission (IEC). The standard provides a framework for ensuring the safety and effectiveness of medical device software, and is widely adopted by medical device manufacturers and developers. IEC 62304 covers a range of topics, including: : Offers a free IEC 62304 Requirement Mapping