Our company specialises in Agile software development, a methodology designed to enhance efficiency, collaboration, and product quality. With Agile, we ensure that your software evolves flexibly to meet the stringent requirements of medical device development, delivering robust solutions that comply with regulatory standards and exceed industry expectations.
For all types of medical device software, whether integrated into a physical device (SiMD), standalone software (SaMD), used in collaboration with an IVD, or as a Clinical Decision Support Software (CDSS), we follow the universally accepted IEC 62304 Medical device software-Software life cycle processes standard.
In our Agile software development process, we conduct regular ceremonies such as sprint planning, daily stand-ups, sprint reviews, and retrospectives. These ceremonies foster transparency, collaboration, and continuous improvement throughout the project lifecycle. Our dedicated Scrum Master plays a pivotal role in facilitating these ceremonies, ensuring smooth communication, and removing obstacles to keep the development process on track.
Moreover, our Agile approach integrates rigorous requirement gathering and quality assurance processes to guarantee the reliability and safety of the software for medical devices. We collaborate closely with stakeholders to gather detailed requirements, prioritise features, and adapt to evolving needs efficiently. We ensure the QA team meticulously tests the software at every stage of development, adhering to industry regulations and producing comprehensive artifacts to ensure traceability and compliance. Experience the benefits of Agile software development with us, where we prioritise customer satisfaction, regulatory compliance, and the delivery of cutting-edge solutions for medical device software.