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Software Medical Device QMS
A Software Medical Device Quality Management System (QMS) refers to the set of procedures, processes, and resources established by a software medical device manufacturer (Standalone or Firmware) to ensure that their software based medical devices meet regulatory requirements and are safe and effective for their intended use throughout the life cycle. ( Software refers to medical device software as well as in vitro diagnostic device software)
IEC 62304 and ISO 13485 Integration
IEC 62304 and ISO 13485 Certification are two key standards relevant to the design, development, verification and maintenance of software medical devices. While they address different aspects of the medical device lifecycle, they are closely related and complementary in ensuring the quality and safety of software medical devices.
IEC 62304 outlines requirements for software development processes, including software development planning, requirements analysis, architectural design, implementation, testing, verification, validation, and maintenance. ISO 13485 outlines the requirements for establishing and maintaining a medical device quality management system, including management responsibility, resource management, product realisation, measurement, analysis, and improvement.
Organisations developing software medical devices must integrate the requirements of IEC 62304 into their quality management system established according to latest ISO 13485. This integration ensures that software development processes are aligned with the organisation’s quality objectives and comply with regulatory requirements.
Both standards emphasise the importance of risk management in the development and maintenance of medical devices. While IEC 62304 provides specific guidance on software risk management, ISO 13485 requires organisations to establish processes for identifying, evaluating, and mitigating risks throughout the product lifecycle, including those related to software.
IEC 62304 & ISO 13485 Integration Table
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Sl.No |
Cl. 13485 |
Title of the Procedure |
Cl. 62304 |
Title of the Procedure |
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01 |
4.1.5 |
Outsourced Process |
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02 |
4.1.6 |
Validation of the application of software used in QMS |
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03 |
4.2.4 |
Control of Documents |
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04 |
4.2.5 |
Control of Records |
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05 |
5.6 |
Management Review |
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06 |
6.2 |
Human Resources |
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07 |
6.3 |
Infrastructure |
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08 |
6.3 |
Maintenance Activities |
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09 |
6.4.1 |
Control of Work Environment |
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10 |
6.4.1 a |
Health, Cleanliness and Clothing |
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11 |
6.4.2 |
Control of Contaminated or Potentially Contaminated Product |
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12 |
6.4.2 |
Contamination Control for Sterile Medical Devices |
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13 |
7.1 |
Risk Management |
7 |
Software Risk management process |
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14 |
7.3 |
Design and Development |
5.1 |
Software Development Planning |
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5.2 |
Software requirements analysis |
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5.3 |
Software architectural design |
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5.4 |
Software detailed design |
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5.5 |
Software unit implementation and verification |
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5.6 |
Software integration and integration testing |
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6 |
Software maintenance process |
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6.3 |
Modification implementation |
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15 |
7.3.7 |
Clinical Evaluation |
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16 |
7.3.8 |
Design & Development Transfer |
5.8 |
Software Release |
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17 |
7.3.9 |
Design & Development Changes |
6.2.3 |
Analyse change requests |
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5.7.1 |
Establish tests for software requirements |
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5.7.3 |
Retest after changes |
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18 |
7.4 |
Purchase Process |
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19 |
7.5.2 |
Cleanliness of the Product |
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20 |
7.5.3 |
Installation and Acceptance Criteria |
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21 |
7.5.4 |
Servicing Activities |
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22 |
7.5.6 |
Validation of processes for production and service provision |
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23 |
7.5.6 |
Validation of the software used in production. |
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24 |
7.5.7 |
Validation of processes for sterilization and sterile barrier systems |
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25 |
7.5.8 |
Product Identification |
8 |
Software configuration management process |
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26 |
7.5.8 |
Identification of returned medical device |
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27 |
7.5.9 |
Traceability |
8 |
Software configuration management process |
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28 |
7.5.11 |
Product Preservation |
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29 |
7.6 |
Monitoring and measuring |
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30 |
7.6 |
Calibration |
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31 |
7.6 |
Validation of Software used for Monitoring and Measurement |
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32 |
8.2.1 |
Feedback process |
6.2 |
Problem and modification analysis |
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33 |
8.2.1 |
Post Market Surveillance |
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34 |
8.2.1 |
Post Market Clinical Follow up |
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35 |
8.2.2 |
Handling of Customer Complaints |
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36 |
8.2.3 |
Notifying the regulatory authorities |
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37 |
8.2.4 |
Internal audit |
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38 |
8.2.6 |
Monitoring & Measurement of Product |
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39 |
8.3 |
Nonconforming product |
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40 |
8.3.3 |
Advisory Notice |
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41 |
8.3.4 |
Rework |
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42 |
8.4 |
Analysis of Data |
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43 |
8.5.2 |
Corrective and Preventive Action |
9 |
Software Problem Resolution Process |