Phase 2 – Software Supporting Documentation based on Level of Concern
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Document Requirements
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Scope of I3CGlobal
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Scope of 510(k) Applicant
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2.1 |
Proposed Labelling |
- Review the User Manual shared by the applicant.
- Create a template.
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- Provide User Manual.
- Provide promotional Material.
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2.2 |
Software Description |
- Provide the list of elements to be include in the device description.
- Prepare the description based on device description details provided by the applicant.
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- Provide the device description details of Device Feature controlled by software, Analysis of Data and Inputs and Outputs.
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2.3 |
System and Software Architecture |
- Provide sample deployment of software architecture.
- Provide the details to be descripted for documentation.
- Review the document provided by the applicant.
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- Provide the software architecture diagram with details regarding
– the modules and layers that make up the system and software
– the relationships among the modules and layers
– the data inputs/outputs and flow of data among the modules and layers
– how users or external products, including IT infrastructure and peripherals interact with the system and software. |
2.4 |
Software Requirement Specifications |
- Provide the details to be descripted for documentation.
- Review the document provided by the applicant.
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Minor Level of concern:
Summary of functional requirements from SRS.Moderate and Major:
- Provide the SRS documents the requirements for the software: detailing the below elements.
– inputs and outputs
– functions that the software will perform
– hardware
– programming language
– compiler version
– performance
– interfaces
– user interaction
-error definition and handling
– response times
-intended operating environment
– safety related requirements derived from a risk assessment. |
2.5 |
Software Design Specifications |
- Provide the list of sections to be descripted for documentation.
- Review the document provided by the applicant.
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Minor Level of Concern:
No documentation is required.Moderate and Major Level of Concern:
- Provide a singular SDS document or set of SDS documents can be used.
Details to be included are:
– technical design details of how the software functions, how the software design completely and correctly implements all the requirements of the SRS and how the software design traces to the SRS in terms of intended use, functionality, safety, and effectiveness.
– software functional units or modules along with the interfaces among them identified in the architectural (i.e., high level) design should be documented with the corresponding detailed (i.e., low-level) design information in the SDS. |
2.6 |
Software Development and Maintenance Practices |
- Provide guidance in documentation.
- Review of documents.
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Minor Level of Concern:
No documentation is required.Major and Moderate level of Concern:
- Provide a Declaration of Conformity to IEC 62304.
OR
Moderate level of concern:
- Provide a summary of the life cycle development plan and a summary of configuration management and maintenance activities.
Major Level of concern:
- All the details of moderate level of concern and Annotated list of control documents generated during development process.
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2.7 |
Software testing as part of verification and validation |
- Review of documents concern to software testing.
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Minor Level of Concern:
System level test plan, including pass/fail criteria and results. Moderate Level of concern:
- Provide a summary description of the testing activities at the unit, integration, and system levels. System level test protocol including expected results, observed results, pass/fail determination, and system level test report.
Major Level of concern:
- Complete details as per moderate level of concern and Test protocol, plan and results of unit and integration of software.
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2.8 |
Risk Management File |
- Provide template of Risk management plan and risk management report covering the all the device related risks.
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- Provide a Risk management plan, risk assessment demonstrating that risks have been appropriately mitigated and risk management report.
- Provide the documentation covering cyber security elements like threat modelling, hazard analysis, trace matrix, mitigation measures etc. If possible, should be provide with separate sections for clear understanding.
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2.9 |
Revision History |
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- Provide the Revision history tabulating the major changes to the software during the development cycle, including date, version number, a brief description of the changes relative to the previous version, and indication of the version on which testing was performed.
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2.10 |
Unresolved Anomalies |
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Minor Level of Concern:
- No Documentation is necessary.
Moderate and Major Level of Concern:
- Provide the List of remaining software anomalies (e.g., bugs, defects) annotated with an explanation of the impact on safety or effectiveness, including operator usage and human factors, workarounds, and timeframe for correction.
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2.11 |
Hardware Requirements |
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- Provide all the hardware involved in the functioning of software device.
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2.12 |
Software Compliance Documents and Certificates |
- Provide the guidance about required elements to be documented in concern to software compliance documents based on the device details provided by applicant.
- Provide the information relates to certification concern to software device based on device details shared by the applicant.
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- Provide all the compliance documents applicable to the software device.
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