R-TF-012-041 Software Classification 62304
Change history
Product: Legit Health Plus Version: 1.1.0.0
Software Safety Classification
This document establishes the software safety classification for Legit Health Plus according to IEC 62304:2006/A1:2015.
Classification Definitions (IEC 62304 Section 4.3)
| Class | Definition |
|---|---|
| Class A | No injury or damage to health is possible |
| Class B | Non-serious injury is possible |
| Class C | Death or serious injury is possible |
Software System Classification
Classification Questions (IEC 62304 Section 4.3)
| Question | Answer |
|---|---|
| Can a hazardous situation arise from a failure of the software? | Yes |
| After taking into consideration risk control measures external to this software system, does failure of the software result in an unacceptable risk? | No |
| What is the worst-case severity of injury that can result from a hazardous situation? | Non-serious injury (Class B) |
Classification Rationale
The classification is based on:
-
Device description: R-TF Device Description and Specification defines Legit Health Plus as a Software as a Medical Device (SaMD) for decision support in dermatological assessment.
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Intended use: Used by healthcare professionals as a decision support tool, not as a standalone diagnostic device.
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Risk analysis: R-TF-013-002 Risk management record documents all identified hazardous situations and their mitigation through external risk control measures.
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External risk control measures:
- Healthcare professional clinical oversight and judgment
- Alternative assessment methods available (traditional clinical examination)
- User training and qualification requirements
- Clear documentation of device limitations in the IFU
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Residual risk: Even in worst-case software failure scenarios, non-serious injury (delayed or suboptimal treatment) is possible, but death or serious injury is not reasonably foreseeable given the external controls.
Software System Classification: Class B
Software Items Classification
According to IEC 62304:2006/A1:2015 Section 4.3, software items inherit the classification of the software system unless segregation is applied.
| Item ID | Software Item Description | Associated Risks | Final Class |
|---|---|---|---|
| ITSW-001 | AI/ML image analysis algorithm | R-DAG, R-SKK, R-B63, R-RAJ | B |
| ITSW-002 | Image quality assessment processor | R-AGQ, R-5L4 | B |
| ITSW-003 | API authentication and authorization module | R-3YJ | A |
| ITSW-004 | Data transmission and communication layer | R-T8Q, R-MWD | A |
| ITSW-005 | FHIR interoperability interface | R-2TP, R-BDR | B |
| ITSW-006 | User interface requirements and output presentation | R-HAX, R-ZFR | B |
| ITSW-007 | Infrastructure and availability management | R-MWD, R-VL1 | A |
Note: Risk IDs reference R-TF-013-002 Risk management record.
Overall Classification
According to IEC 62304:2006/A1:2015, the overall software system classification is determined by the highest classification of any software item.
- Class B items: ITSW-001, ITSW-002, ITSW-005, ITSW-006
- Class A items: ITSW-003, ITSW-004, ITSW-007
Overall Software Classification: Class B
Segregation Analysis
Segregation analysis per IEC 62304:2006/A1:2015 Section 4.3.d is not required as:
- No Class C software items are present
- Class A items (ITSW-003, ITSW-004, ITSW-007) are already segregated by design and do not contribute to clinical decision-making risks
Verification of risk control measures implementation is documented in:
- R-TF-012-035 Software Test Report
- R-TF-012-043 Traceability Matrix
References
| Document | Description |
|---|---|
| R-TF Device Description and Specification | Device description and intended use |
| R-TF-013-001 Risk management plan | Risk management methodology |
| R-TF-013-002 Risk management record | Hazard identification and risk control measures |
| R-TF-013-003 Risk management report | Risk acceptability conclusions |
| R-TF-012-028 Software Requirement Specification (SRS) | Software requirements |
| R-TF-012-035 Software Test Report | Verification of risk controls |
| R-TF-012-043 Traceability Matrix | Requirements to tests traceability |
Signature meaning
The signatures for the approval process of this document can be found in the verified commits at the repository for the QMS. As a reference, the team members who are expected to participate in this document and their roles in the approval process, as defined in Annex I Responsibility Matrix of the GP-001, are:
- Author: Team members involved
- Reviewer: JD-003 Design & Development Manager, JD-004 Quality Manager & PRRC
- Approver: JD-001 General Manager