Medical device software development

Medical device software development is an evolving field within the medical device industry—growing more complex each day to keep up with the need for enhanced patient care and therapies. Sterling Medical Devices will guide you through every step of the medical device software development lifecycle to ensure you develop a safe, effective, and FDA/IEC 62304-compliant product.

Medical device software development services include specification creation, software coding and testing, and integration with a device. ISO 13485 certification and 17 years of healthcare IT experience back up ScienceSoft’s skills in creating secure SaMD and software for medical devices.

Medical device firmware: Embedded medical device software design is a significant step within the development process, as each medical device must have a reliable, real-time operating system interface and controls for its subsystem. Our firmware experts at Sterling Medical Devices will design and implement embedded medical device software that addresses the needs that are unique to your device.

Software development for medical devices

In this article, we’ll discuss custom medical device software development. The new generation of healthcare startups and companies offers innovative, portable, convenient medical devices for a variety of healthcare situations and needs. The relatively new concept of “Software as a Medical Device” (SaMD) is unveiling huge opportunities in the creation of advanced applications for existing or prototyped medical devices.

With the advancement of technology, the world is now adopting Software in medical devices for various purposes and it is now a important part to know more about medical device software development process. Using Software as a medical device is not an easy task. Still, it has taken the world of medicines to a newer height where diagnosing any disease, disorder, or condition is very easy. Since the treatment route decided by professionals mostly depends on the diagnosis done by the SaMD, it is very important to have stricter regulations to regulate so that there is no space for any serious incidents. As a medical device regulatory consultant we are guiding new entrepreneurs and device makers for the regulatory compliance

Software as a Medical Device may be interfaced with other medical devices, including hardware medical devices, and other software as a medical device software, as well as general purpose software. Software that provides parameters that become the input for a different hardware medical device or other Software as a Medical Device. For example, treatment planning software that supplies information used in a linear accelerator is Software as a Medical Device.

Medical device software development tips

Whether you need the end-to-end development of medical device software, existing software modernization, or medical device software development consulting, our team of seasoned business analysts, experienced developers, and QA specialists is at your service.

There are different software classifications specific to medical equipment. Before starting a new project, it’s necessary to clearly define the requirements for your medical device software development, as the scope and technologies can be pretty diverse, including embedded coding and SaMD.

Do you need to build your medical device software from scratch? Or do you have an ongoing project that requires additional augmentation and resources? Finding and choosing the right medical device software developers can be a very challenging task. Here are a few recommendations on hiring a good team for your project: