Medical device software development refers to the process of planning, designing, developing, and testing software applications intended for use in or as medical devices. Whether you are a MedTech startup seeking your first FDA approval, a mid-sized company going digital, or a leading medical device manufacturer looking to outsource your engineering needs, we have you covered.

Rubedos medical device software development services are ISO 13485 and IEC 62304 compliant and backed by over 15 years of experience in the healthcare industry. We rely on proven software architecture and project management practices to design and build secure, MDR- and FDA-cleared SaMDs and SiMDs. Tap into our infrastructure and expertise in robotics and computer vision and watch your idea become a product. Depending on your resource gap, offload only testing and performance evaluation activities, for example.

We enjoy working on projects in the medical field with a quality-driven approach to medical device software development. Our track record includes diagnostic devices, health monitors, and C-classified medical devices such as a 6D patient positioning system under a linear accelerator, providing quality- focused software development and testing.

Our team can work alongside existing in-house teams or be your provider of the full engineering service stack for medical NPD. If needed, we can conduct a skills gap analysis and recommend a suitable team to fill those gaps. We also have a verification and validation team that can integrate with your larger multidisciplinary team. If required, we can work with clients to explore the creation of a custom automated test solution.