Software Life Cycle Processes for Medical Devices
Sep 15, 2021
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In the modern world, software is one of the crucial elements of most medical devices.
In the modern world, software is one of the crucial elements of most medical devices. To create an effective, practical, and, most importantly, safe package of applied programs for medical equipment, engineers use uniform medical software development guidelines that determine requirements at the following stages:
- initial system design
- installation and maintenance
- solutions to all technical errors and shortcomings
- removal from service
The developer is obliged to adhere to quality standards based on applicable legal requirements. Namely, IEC 62304 defines life cycle requirements for medical software development. It is used as a reference to meet regulations for quality control, risk management, and safety classification. This standard covers the following stages:
- building a software development plan
- review of additional requirements
- software design engineering
- working on a software module
- software integration and validation
- final tests
Software Release
The next standard to be adhered to during the design stages is IEC 82304-1. Compliance with the requirements is determined by reviewing all documentation provided for its content. The main focus is placed on the requirements for developers, as well as the software security, regardless of the hardware. One of the main points applies to the maintenance of the software product after its release for the intended use, namely:
a) correction of errors identified
b) adaptation to a new hardware or software platform
c) improvement when new requirements are introduced
d) preventive measures to make the product easier to maintain
The technical standard IEC 60601-1 is recognized as the benchmark for medical electrical equipment. The standard requires documentation, the basic characteristics and configuration of a network, and the concept of a safety system for medical electrical equipment, medical electrical systems, and software used in healthcare. In addition, the distributor should draw the user's attention to the risks associated with the network integration of the software in relation to data integrity and security.