As medical devices become increasingly sophisticated, the ability to produce reliable and highly maintainable software is critical. From developing component-based software architectures to implementing practical software process improvement, Proven Process leans upon decades of experience and knowledge in creating and fully validating software to meet customer needs.
Our software engineers use a structured development process that complies with domestic and international standards, including FDA Software Guidances, ANSI/AAMI/IEC 62304 and EN 60601-1. Regardless of the software function, our expertise in the most advanced development methods and technologies ensures the best quality deliverable. We specialize in quick delivery of quality solutions to clients, while maintaining great flexibility to new regulatory requirements and changing client needs.
Our software engineers work with Windows, Linux, Android, QNX, and other real-time operating systems, and program in most major languages. We specialize in developing embedded firmware for medical devices as well as software solutions for distributed processing systems with sophisticated Graphical User Interfaces (GUI). We also design software for connected devices which use wireless communication for IoT, mobile, or Cloud-based applications. Employing advanced technologies our solutions are designed to the highest standards of performance, reliability, safety, and flexibility for our client’s needs.
User Experience and User Interface Design
Medical device software must be fast, responsive, secure, and easily parsed by new users. Clinicians need to be able to quickly train in a software’s use and understand its functionality. Patients want user-friendly, accessible, appealing software that engages them and helps them easily manage their health.
Designing such innovative User Experiences requires a deep understanding of a software’s purpose, the workflows and solutions it enables, and how it will fit into a provider’s or a patient’s life. Proven Process works with clients to design clinician and patient-friendly software to accompany our devices, like the custom GUI for medical-grade tablets that accompanies our Infusion Rate Monitor.
Connected Devices and the Internet of Things (IoT)
Proven Process has extensive experience with connected devices. Our device designs prioritize reliable operation and data security, with threat modelling and penetration testing employed at all levels of development to ensure maximum security against outside threats. Whether designed for IoT connectivity, Cloud-based infrastructures, or mobile devices, we design solutions and accompanying software like our continuous blood glucose monitor for user-friendly operation and efficient performance - all while keeping costs down and operating within client and regulatory needs.
Medical device manufacturers must comply with International standards that ensure the quality and reliability of the medical device’s software. In addition, medical device manufacturers must meet the standards for the specific markets in which the device will be used. As an ISO 13485:2016 and FDA-certified manufacturer, Proven Process’s team of software engineers are intimately familiar with the changing regulations inherent to medical device software development. We design our software solutions with current and future regulatory requirements in mind, so that our programs and devices are highly flexible and easily adaptable to new compliance demands.
At Proven Process, we’ve designed and developed software for a wide variety of sensitive medical applications, from patient monitoring equipment and electrosurgical tools to home use medical devices, implantable infusion pumps and drive systems for VADs and temporary total artificial hearts. Whatever kind of software solution you require, our highly experienced team of engineers can take you from concept to design, quality assurance, and release. Contact us today to learn more.