Medical software
Software is increasingly at the heart of successful medical devices, improving the lives of patients and providing important data to clinicians and healthcare providers. At DCA we have the people, the experience, the processes and the passion to design and develop high quality, compliant medical device software to deliver success.
Our experienced software team will work with you to develop a tailored plan for your product that effectively navigates the regulatory requirements. We will bring our attention-to-detail and intelligent approach to the development and support you in making informed decisions, managing safety and cybersecurity risks, and developing a great user experience.
Our approach is founded on our ISO 13485 certified Quality Management System and our transparent evidence based philosophy. This is complemented by our mature development methods and processes, which are underpinned by the IEC 62304, ISO 14971, ISO 62366 standards and FDA regulation.
We’ll work with you to develop a tailored plan for your product
Software risk management
The backbone of any successful medical software project is a solid risk management process. We can help you determine the software safety classification of your product and identify its potential hazards. We conduct risk analysis from the moment we start gathering requirements all the way through to design verification. Identifying risks early allows for effective and appropriate risk mitigations to be implemented as an integral part of development rather than as an afterthought, improving the safety and the usability of your product, as well as the efficiency of the development programme.
Generating the appropriate software risk management documentation is almost as crucial as the process itself. We have template documents that make capturing the details and presenting them for audit efficient and successful. We can also adapt to any specific format you may require.
Software of unknown provenence
Increasing system complexity means that software engineers now often face the choice of whether to “make, buy or use open source” for software building blocks.
We take the time to properly evaluate the code in question and the integrity and traceability requirements of the intended application before deciding whether software of unknown provenance (SOUP) is a viable option. In so doing, we can minimise the project risk, maximise the re-use of trusted code and focus on your specific application requirements.
Controlled re-use of trusted code
