At RTEmd, we’ve been helping major medical device manufacturers and innovators launch successful new products for almost 30 years.
Our services cover the complete spectrum of software development, from requirements analysis, architecture, and design, to helping you compile documentation for your Design History File and assisting with your regulatory submission.
Our work involves two interfaces:
Between your core technology (for example, sensors, or detection mechanisms) and the device that makes it functional. We develop software to control sample preparation, machine calibration, incubation, data acquisition, algorithms for results processing, the operator interface, and results reporting.
Between your products and the information flow in which they operate. We develop instrument interfaces to the LIS, RIS and HIS, and remote diagnostic connections for field service.
We're ready when you are
By taking a disciplined and efficient approach to new product development, we help our customers bring important new medical devices to market quickly. And we're ready to help you. Here's what we bring to the table:
- We make short work of the learning curve. Our seasoned team has the depth and breadth of experience to quickly understand your culture, your technology, and your objectives. That means we can get your project off to a fast, flawless start.
- We have a big-picture, whole-systems perspective. We view our work as an integral part of your product, not as an isolated task. We work hard to develop software that interfaces seamlessly with all the other systems and components. And we take the time to build productive relationships with your stakeholders.
- We scale our services to meet your needs. Whether you want us to manage the development of an entire system or a single module, RTEmd will provide the expert advice and turnkey assistance you need.
- We help you define the right requirements. We use our in-depth understanding of medical device development to help you translate marketing objectives into rock-solid software requirements. The result? You’ll accelerate your time to market and prevent costly revisions and fixes before, during, and after your launch.
- We meet tight deadlines with disciplined development. We continuously improve our development process to maximize our efficiency and cost-effectiveness. We also have the experience and flexibility to follow your internal process to the letter.
- We have extensive experience with highly complex medical devices. We help our clients launch everything from sophisticated and highly sensitive blood analyzers to state-of-the-art imaging diagnostics technologies. Whether you want to implement functionality or ensure connectivity, we can help.
- We create documentation that’s ready for your Design History File. Our expertise in documentation reflects our in-depth understanding of the FDA’s Quality System Requirements. So you can count on us to provide the meticulous detail you need to facilitate review and approval. In fact, many of our clients rely on us to document their in-house software development efforts.
We welcome the opportunity to talk with you about helping you develop your next breakthrough product. For more information, contact us today.
