We can help you design a product that performs best in the real world. Over the years, our engineers have logged more experience building, implementing, and integrating medical device systems into clinical environments than any other independent U.S.-based company. We understand the limitations and infrastructural challenges inherent in a wide range of clinical environments.
True Process has a great deal of experience working within FDA-regulated quality systems. We are ISO 13485 certified and fully understand the strict design and documentation controls required in our industry. We have in-house regulatory expertise, understand the 510(k) process, and can offer advice on methods to streamline premarket submissions.
True Process has embraced Agile methodology since 2013, utilizing it to bring efficiency and accountability to our software engineering practices. Through Agile, we are able to quickly prioritize critical requirements, evaluate risks and hazards, and mitigate the impact of inevitable changes. We also promote lean product development which is particularly helpful in prototyping and getting a product to market quickly.
We pride ourselves in our ability to lead projects through the entire software product lifecycle, from ideation, requirements, prototyping, design, development, testing, and beyond. Because we provide medical device installation, integration, and support services, we can provide critical insight into real-world product performance.
We strive to provide our clients with the best possible solution, no shortcuts or band-aid fixes. When you work with True Process, you will work with a company whose mission is to be with you as a trusted, long-term partner. Bring us challenges and we’ll bring back solutions. Expect that our conversations will be honest, our solutions will be well-engineered, and our dedication unwavering.