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Medical Software Engineering

We Are Experts in Agile Medical Software Engineering & Connected Medical Devices

Over the past 14 years, True Process has distinguished itself as a leader in medical software engineering and prototyping. We have pronounced experience with connected medical devices, having developed a wide-range of software solutions for both our medical device manufacturer partners and for our healthcare software products.

We understand the challenges of engineering medical software and technology solutions under strict quality systems that are subject to FDA compliance. The team at True Process will help you every step of the way—from development, to documentation, to delivering your solution. Our engineering division includes a smart, experienced team of software developers, network engineers, system architects, business analysts, and regulatory compliance engineers.



C, C++, C#





Full Stack Development

Mobile - IOS, Android

Cloud Based - AWS, Azure

Embedded Systems

DB - SQL, MySQL, Mongo

Connectivity: Binary, XML, HL7, IHE, FHIR, JSON

ISO 13845 certified/FDA Compliant

HI-TRUST compliant

Atlassian Suite (Jira, Confluence, BitBucket)


Real-World Clinical Experience

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.


Product Focused

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.


An Honest, Principled Partner

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.

Contact us for more information about our medical software development and prototyping solutions.