sop-integrated-software-development

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SOP Integrated Software Development

Classes IEC 62304:2006 Section Document Section
A, B, C 5.1.2 4
A, B, C 5.2.1 4
A, B, C 5.2.4 3, 7, 10
A, B, C 5.2.5 4
A, B, C 5.2.6 5
B, C 5.3.1 6
B, C 5.3.2 6
C 5.3.5
B, C 5.3.6 6
B, C 5.4.1 6
C 5.4.2
C 5.4.3
C 5.4.4
A, B, C 5.5.1 6
B, C 5.5.2 7
B, C 5.5.3 7
C 5.5.4
B, C 5.5.5 7
B, C 5.6.1 7
B, C 5.6.2 7
B, C 5.6.3 8
B, C 5.6.4 8
B, C 5.6.5 8
B, C 5.6.6 8
B, C 5.6.7 8
A, B, C 5.7.3 8
A, B, C 5.7.4 8
A, B, C 5.7.5 8
A, B, C 5.8.1 7
A, B, C 5.8.2 11
A, B, C 5.8.4 11
B, C 5.8.5 11
B, C 5.8.6 11
A, B, C 5.8.7 11
A, B, C 5.8.8 11
B, C 7.1.1 2, 3, 6, 8, 10
B, C 7.1.2 2, 3, 6, 8, 10
B, C 7.1.3 6, 12
B, C 7.1.4 2, 3, 6, 8, 10
B, C 7.2.1 2, 3, 6, 8, 10
B, C 7.2.2 2, 3, 6, 8, 10
B, C 7.3.1 7
B, C 7.3.3 9
A, B, C 8.1.2 4, 6, 8
A, B, C 8.1.3 11
A, B, C 9.8 8
ISO 14971:2019 Section Document Section
4.1 3, 4, 5, 6, 8, 9, 10, 11
5.1 3, 4, 5, 6, 8, 9, 10, 11
5.3 3, 4
5.4 3, 4
5.5 3, 4
6 3, 4
7.1 3, 4, 5
7.2 6
7.3 6, 10
7.4 10
7.5 6
7.6 10
8 10
9 10
IEC 62366-1:2015 Section Title Document Section
4.1.1 Usability Engineering Process (All)
5.1 Prepare Use Specification 4
5.8 Perform User Interface design, implementation and Formative Evaluation 4, 5, 6, 7

Summary

This SOP describes how software as a medical device is developed. It integrates risk management and usability engineering activities into the process.

General Notes

Integrated Process, Evolutionary Strategy

This process integrates risk management and usability evaluation activities into the software development process. It therefore covers requirements of IEC 62304, ISO 14971 and IEC 62366. There are no separate risk management and usability engineering processes.

The Software Development Process described in this SOP resembles an “evolutionary” strategy (IEC 62304:2006, Annex B), acknowledging that the user need is not fully understood and not all requirements are defined up front. Whenever requirements change, the preceding process steps and their outputs need to be re-done to ensure consistent and complete documentation.

Process Steps

1. Design Input

Based on business input and product ideas, a device description and vision document is created to describe the high-level vision of the planned product. Technical input is considered for whether the idea is feasible.

Business input could be:

Changes to the product also enter the process here (i.e., as change request as defined in SOP Change Management).

Participants
CEO
CTO
CPO
Input Output
Business input Device Description
Technical input Vision document
Product ideas
Change Request

2. Usability Engineering and Risk Management Planning

The risk management and usability engineering activities are planned and documented. The Usability Evaluation Plan includes summative and formative usability evaluation activities.

Participants
CPO
Subject matter experts, e.g. physicians
Input Output
Device description Risk Management Plan
Usability Evaluation Plan

3. First Risk and Usability Assessment

In the first risk and usability assessment, a preliminary hazard analysis is conducted and an initial risk table is drafted. The risk table includes the risk policy with a risk acceptance matrix.

The Risk Acceptance Matrix is defined by performing these steps:

Risk analysis is performed by conducting a Failure Mode and Effects Analysis (FMEA). It includes the following activities:

In general, we try to reduce probabilities of risks as low as reasonably possible (ALARP).

If a risk is deemed unacceptable based on our Risk Policy, it may be mitigated through Risk Control Measures:

A usability evaluation plan is created which covers future formative and summative usability evaluation activities.

Usage scenarios with a focus on those related to hazards are specified. These will serve as input to the summative usability evaluation.

Participants
CPO
Subject matter experts, e.g. physicians
Input Output
Device description Preliminary Hazards Analysis
Risk Management Plan Risk table incl. Risk Acceptance Matrix (draft)
Usability Evaluation Plan Software Safety Classification (draft)
Usage Scenarios

4. Software Planning

Based on the device description, the usage scenarios and preliminary risk analysis, the next steps is to plan software development by defining software requirements. These also include the user interface specification, e.g. wireframes, mockups or style guides.

The software system test plan is created based on the requirements. As requirements may change, the software system test plan is continuously updated to reflect those changes.

Software requirements are verified through review by filling out the Checklist Software Requirements Review.

Participants
CTO
Software Engineer
Risk Manager
Usability Engineer
Input Output
Device Description Software Development and Maintenance Plan
Vision Document Software Requirements incl. User Interface Specification
Change Request Software System Test Plan
Risk Table (draft) Risk Table (updated)
Preliminary Hazards Analysis

5. First Review: Software Planning Review

Software requirements are reviewed. If the review is successful, move forward to the next step. If it’s not, the software requirements have to be reworked with possible changes to the risk analysis and usage scenarios. In that case, move back to the relevant step above.

Participants
CTO
CPO
Risk Manager
Usability Engineer
Subject matter experts, e.g. physicians
Input Output
Software Requirements Checklist Software Requirements (filled out)
Risk Table (draft)
Usage Scenarios

6. Software Architecture, Detailed Design and Implementation

A software architecture is created (and detailed design, if necessary). As the software development process follows agile methodology, the software architecture may change as new knowledge is gained during implementation. The end result should be that both the implementation and the documented software architecture are synchronised.

At minimum, an architecture diagram showing all software systems including databases and networks is created. For each software system, public interfaces, are documented, e.g. REST APIs, internal methods.

SOUP is added/updated here, if necessary. For each SOUP, we specify the name, version, manufacturer, website link (incl. release notes and issue tracker), requirements and prerequisites. SOUP must be verified before moving to the next step. Possible SOUP verification criteria include sufficient test coverage by the author and being commonly used; correct SOUP functioning is also verified through software verification and software system testing in the following steps.

If new risks relating to software units and potential failure modes are discovered during this phase, they are added to the risk table.

Participants
CTO
Software Engineer
Input Output
Software Development and Maintenance Plan Implemented Software Items, i.e. code
Software Requirements Software Architecture (created/updated)
Software System Test Plan Software Detailed Design (created/updated)
SOUP list (created/updated)
Risk Table (updated)

7. Second Review, Verification, Formative Usability Evaluation, Integration

The second review covers multiple activities:

Code review is conducted based on the following criteria:

Upon successful verification, the implemented software requirement is integrated into the current code base as described in the Software Development and Maintenance Plan. The software units may be integrated only if all activities above were successful.

Participants
Software Engineer
Usability Engineer
Input Output
Implemented Software Unit(s) incl. User Interface Code review result
Unit / Integration test result(s)
Formative Usability Evaluation Assessment

8. Software System Testing

Based on the Software System Test Plan, software system tests covering all software requirements are performed.

If new risks are discovered during the system tests, they are added to the risk table.

If anomalies are encountered, they are added to the list of known anomalies and/or entered as new software requirements to be fixed.

Participants
Software Engineer
Input Output
Software System Test Plan Software System Test Protocols
Software System Test Report
Risk Table (updated)
List of known anomalies (updated)

9. Validation / Summative Usability Evaluation

Validation is done as summative usability evaluation.

A Usability Test is conducted in the context of the actual usage scenarios in accordance with the Usability Evaluation Plan.

If new risks are discovered during the usability tests, they are added to the risk table.

Participants
CPO
Usability Engineer
Users for Usability Test
Input Output
Usage Scenarios Usability Test Protocol(s)
Labeling and Instructions for Use, if applicable Summative Evaluation Report
Usability Evaluation Plan Risk Table (updated)

10. Final Risk Assessment and Risk-Benefit Analysis

The overall risk of the product is evaluated by analyzing all identified risks so far. If unacceptable risks exist, they are weighed against the benefits of the Medical Device as proclaimed by the Clinical Evaluation. We only continue to release the Medical Device if the benefits outweigh the risks.

If unacceptable risks remain which are not outweighed by the benefits, we consider adding new risk control measures and move back in to the relevant step in the process.

The finalization of the Risk Management Report is the prerequisite for finalizing the Software Safety Classification.

Participants
CEO
CTO
CPO
Input Output
Preliminary Hazards Analysis Risk Management Report
Risk Table Software Safety Classification (final)
Clinical Evaluation
Software (Release Candidate)

11. Release

Before release, it is ensured that all required processes (Software Development, Usability Evaluation, Risk Analysis) have been completed. Release notes are created which include the list of known anomalies. The software is only released if the remaining anomalies are deemed acceptable. A version number in accordance with the Software Development and Maintenance Plan is assigned.

Participants
CTO
Input Output
Device Description Released Software
Checklist Release Checklist Release (filled out)
Risk Analysis Release Notes incl. list of known anomalies
Usage Scenarios
Software Requirements
Software Architecture and Detailed Design
Software Items incl. Verification
Software System Test Report
Usability Evaluation Results

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