There has been much debate about last month’s publication of revised guidance from the MHRA on software and programmable devices, bringing forward concerns about the vulnerability and quality of critical software embedded in increasingly sophisticated medical devices.
Manufacturers of medical devices have a responsibility to ensure their products comply with necessary standards and guidelines in their countries to be able to take the product to market, and protect their end users; providing the safest, highest quality experience possible. This includes the software within those devices.
The BS EN 62304 and IEC 62304 standards, for example, specify life cycle requirements for the development of medical device software. These standards categorise the software into three different definitions:
- Class A: No injury or damage to health is possible from using the software
- Class B: Non-serious injury is possible from using the software
- Class C: Death or serious injury is possible from using the software
The medical device software is categorised depending on their intended applications. For example, those categorised with Class C will include devices that will be used in a situation where a malfunction could pose a serious risk to users. Therefore it is incredibly important that the software within the device is written with quality, and these standards, in mind.
But it’s not just compliance issues that should be considered when analysing the quality of your medical device’s embedded software. The way your software is aligned with the overall branding of your product, and your own brand, plays an important part in how well the device will be received by your target market.
For example, if the user interface and the way the customer interacts with your product doesn’t work as they expect, it can call into question the quality and reliability of the product and your company. Bugs and glitches in a device that will be used in high-risk situations can seriously damage the user’s trust and perception of your entire brand.
We have over 10 years experience working with large, blue-chip clients, such as Veolia Water, in the scientific and medical sectors, where software quality is imperative for the safety and success of the products.
We believe one of the best ways overcome these concerns with compliance, branding trust, and overall quality, is to get an objective review of your existing software that focuses on key quality indicators, such as test coverage and cyclomatic complexity.
Infact, we have recently launched a service that does just that. The Illumination service is a Software Quality Assessment; an analysis completed by some of our senior engineers that will highlight issues, gaps and recommended actions to improve software quality in a simple report.
This service is cost and obligation free, and the report can be used to share between management and your existing development team to help you understand what areas in the software to focus on and how you may want to proceed with further development.
An objective review like this from a third party who take quality seriously and have experience in this demanding sector can help to steer a software project onto the right tracks.