1. Level of Concern
A statement indicating the Level of Concern and a description of the rationale for that level.
Table 1 Major Level of concern
If the answer to any one question below is Yes, the Level of Concern for the Software Device is likely to be Major.
1. Does the Software Device qualify as Blood Establishment Computer Software? (Blood Establishment Computer Software is defined as software products intended for use in the manufacture of blood and blood components or for the maintenance of data that blood establishment personnel use in making decisions regarding the suitability of donors and the release of blood or blood components for transfusion or further manufacture.)
2. Is the Software Device intended to be used in combination with a drug or biologic?
3. Is the Software Device an accessory to a medical device that has a Major Level of Concern?
4. Prior to mitigation of hazards, could a failure of the Software Device result in death or serious injury, either to a patient or to a user of the device? Examples of this include the following:
a. Does the Software Device control a life supporting or life sustaining function?
b. Does the Software Device control the delivery of potentially harmful energy that could result in death or serious injury, such as radiation treatment systems, defibrillators, and ablation generators?
c. Does the Software Device control the delivery of treatment or therapy such that an error or malfunction could result in death or serious injury?
d. Does the Software Device provide diagnostic information that directly drives a decision regarding treatment or therapy, such that if misapplied it could result in serious injury or death?
e. Does the Software Device provide vital signs monitoring and alarms for potentially life threatening situations in which medical intervention is necessary?
Table 2 Moderate Level of Concern
If the Software Device is not Major Level of Concern and the answer to any one question below is Yes, the Level of Concern is likely to be Moderate .
1. Is the Software Device an accessory to a medical device that has a Moderate Level of Concern?
2. Prior to mitigation of hazards, could a failure of the Software Device result in Minor Injury, either to a patient or to a user of the device?
3. Could a malfunction of, or a latent design flaw in, the Software Device lead to an erroneous diagnosis or a delay in delivery of appropriate medical care that would likely lead to Minor Injury?
If the answers to all of the questions in Tables 1 and 2 above are No, the Level of Concern is Minor.
2. Software Description
A summary overview of the features and software operating environment.
3. Device Hazard Analysis
Tabular description of identified hardware and software hazards, including severity assessment and mitigations
4. Software Requirements Specification (SRS)
5. Architecture Design Chart
6. Software Design Specification (SDS)
7. Traceability Analysis
Traceability among requirements, specifications, identified hazards and mitigations, and Verification and Validation testing.
8. Software Development Environment Description
9. Verification and Validation documentation
10. Revision Level History
11. Unresolved Anomalies((Bugs or Defects)