RBC Medical Innovations has a custom medical device software design and development process specifically tailored for embedded software. Let us share it with you.
The first medical device software development question is selecting the best software for application performance, given interactions between software operating system and target hardware. Considerations include:
Medical Device Design & Development Services
- Should you select a Real-Time Operating System (RTOS) or a General Purpose OS (GPOS) such as Android or Linux?
- What are system’s physical limits for portability and functionality requirements?
- How much power will be needed to power the device?
- How will we ensure the device controlling software works without harming the patient?
- How will the system collect and report procedural information while ensuring patient privacy and data encryption?
- Do you have a documented system to keep current with FDA and IEC 62304 regulations?
Our medical device software development company can help you with:
- Embedded Software and Firmware Development. RBC Medical Innovations’ embedded software engineers are experienced in all aspects of embedded software/firmware development—from the simple (micro-power 8-bit designs using Assembly and ANSI C) to the complex (30+ MIPS, ARM, DSP, X86-based multiprocessor systems using off-the-shelf or custom RTOS). RBC embedded software designs emphasize quality, safety, testability and maintainability, and our architectures leverage reuse wherever possible.
- PC-Based Software Application Development. Our work on the this particular information system is a fitting example of our PC-based software work. We drafted proposals, managed the schedule, budget and risks; updated requirements and system risk analyses, and developed requirements for and implementing a standalone video configuration application. Related tasks for medical device software development include creating an automated test fixture, performing clinical data analysis, and allowing for device software updates. We remain current with the latest high-level languages and platforms.
- iOS Developer and MFi Developer Programs. RBC Medical Innovations is licensed to develop electronic accessories and software applications designed for use with the iPhone®, iPad® or iPod®. With 23 years’ experience developing FDA cleared electro-mechanical medical devices using embedded software, we can deliver successful home use medical devices for distribution on the App StoreSM.
Embedding your medical device software in the proper enclosure.
Visit other tabs on our site for examples of the medical device design work we’ve done to house the medical device software development project. Then contact RBC when you’re ready to get started!
510(K), PMA, AND CE MARK SUBMISSIONS
Depending on your needs, RBC Medical Innovations can produce all or part of the design documentation required for a FDA 510(k) submission, pre-market approval, or a CE Mark technical file.