EMBEDDED SOFTWARE FOR MEDICAL DEVICES: ENSURING SAFETY AND COMPLIANCE
Embedded software plays a critical role in modern medical devices. Whether it’s controlling insulin pumps, diagnostic imaging systems, or pacemaker programming, ensuring safety and compliance is paramount. Let’s explore the key aspects:
iec 62304: REGULATION OF MEDICAL DEVICE SOFTWARE
The IEC 62304 standard provides guidelines for managing the lifecycle of medical device software. It applies to both embedded software within devices and Software as a Medical Device (SaMD).
The standard covers all aspects of software development, from requirements through design, code and object code, and places an obligation on a manufacturer to ensure that the software running the medical device is fit for purpose.
The main focus of the standard is that the software produced is behaviourally robust. What that means is that, not only that it does what it should, (and not do what it shouldn’t) but that the manufacturer must be able to prove this also.
This can be a difficult and hugely expensive task, requiring expertise in the form of many specialist engineering work hours.
YOUR OBLIGATIONS AS A MANUFACTURER
However, with the D-RisQ tool suite, you do not need that. The expertise is in the tools and they in turn, automate most of the processes and checks required by the standard. Furthermore, they provide the evidence that the software has been properly verified, is robust and that it would meet the needs of a regulator.
IEC 62304 is a globally recognised standard and is not prescriptive in how a manufacturer develops its embedded software.
This might be a concern for medical device developers, particularly those that will be developing embedded real-time control systems.
In any medical device software development, you will need to:
Develop plans, and be able to say to the regulator what the software device will do and will not do (requirements at the system and software level)
Produce a software architecture and detailed design
Implement it in code, and integrate it
And undertake verification throughout each stage of the life cycle.
You will also need to produce the documentation that supports system validation as well as the evidence to support software verification.
HOW CAN THE D-RISQ TOOL SUITE HELP?
Our tools will provide the requisite evidence you require to ensure that your embedded software complies with IEC 62304. By using the D-RisQ automated tool suite, manufacturers can develop and verify, safe and effective control systems for medical devices that meet the needs of patients and healthcare providers.
The D-RisQ tool suite supports the manufacturer of medical devices and their software development team, in adhering to best practices and the IEC 62304 standard.
They are accessible and user friendly - no special training required.
Your team do not have to be experts in IEC 62304 – the expertise is in the tools.
Our tools will support proof of compliance to IEC 62304, allowing rapid certification of your product.
Using our tools can reduce the costs by 50-80%. This supports manufacturers in creating safe, effective, and compliant embedded software for medical devices in an accessible way.
You can commercialise and get your device to market faster.
We can also provide further support through our D-RisQ software services consultancy, for a more bespoke approach.
SUCCESS IN REDUCING COST AND SAVING TIME
In a recent medical device project, the D-RisQ tools have allowed cost-effective and expedited compliance, highlighting the value of automated formal methods-based tools to drive innovation in medical device software. This partnership represents a landmark step toward safer, more efficient medical devices, underscoring D-RisQ’s commitment to developing medical technology that saves lives and meets the highest levels of software assurance.
The project demonstrated the power of automated formal verification tools in software development. By using D-RisQ requirements tools for systems and software (System Kapture®, Kapture®) combined with D-RisQ Design verification tool Modelworks® and D-RisQ's CLawZ® source code verification, errors were uncovered and quickly rectified throughout the development process. Early identification of issues led to a more efficient development, saving both time and costs. The tools not only simplified compliance with stringent medical software standards but also demonstrated the viability of using formal methods in automated tools to deliver complex systems within tighter deadlines and reduced budgets.
D-RisQ’s tool suite, with its automated and formal methods-based approach, can revolutionise the development of embedded software for medical devices, making it more accessible, cost-effective, and assured. It underscores that with the right tools, medical device developers can bring innovative, life-saving technologies to market faster while maintaining the highest standards of safety and compliance.
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D-RisQ empowers medical device developers to build safe, effective products faster and more affordably. With tools that ensure compliance and minimize costs, bringing cutting-edge technology to market has never been easier. Explore how D-RisQ can support your next innovation in medical technology.
Click here for a free factsheet on how to get to get to market with the right embedded software.
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