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Learn How Working With True Process Will Get Your Medical Software Projects Off the Ground

Chuck and Joe from True ProcessThe decision to engage with a third-party provider of software engineering services is never made lightly – outsourcing can be an anxiety-inducing experience for even the most seasoned project manager.

We get it. It’s a stressful endeavor. Outsourcing can feel like you are ceding control of your project and adding another moving part to an already complex operation. However, we are here to assure you that outsourcing your project to a smart, project-based engineering firm like True Process will actually alleviate stress.

In response to the pre-project engagement jitters we encounter with many of our clients, we thought it would be helpful to explain what it’s like to work with us. Contrary to popular belief, outsourcing does not have to be a stressful process.

Read on to find out how True Process can help you meet your engineering goals, stay on schedule,  within budget, and provide a product that meets regulatory scrutiny and documentation needs.

What Kind of Work Do We Do?

True Process specializes in software engineering for the healthcare industry. We have exceptional experience in connected medical devices and can help with everything from software applications and plug-ins to embedded systems and product prototypes.

We pride ourselves on being able to provide expert advice and smart, creative engineering. We are more than a staffing agency. True Process delivers project-based software engineering solutions for companies that require a partner able to assist them in all aspects of medical software development —including design, engineering, testing, deployment, support, and regulatory assistance.

How are We Different?

From our very first consultation to the final stages of a project, True Process strives to provide peace of mind. As such, we treat each project as if it were our own. Instead of maximizing client sales, we look to maximize long-lasting relationships built on a foundation of communication and trust. We will provide honest feedback and realistic assessments of project viability. When you partner with True Process, you will receive new perspectives and approaches toward solving your engineering problems.

How to Engage Us

Our process always starts with a conversation.

We seek to understand your challenges and your opportunities, budgets and timelines. We will highlight our experience and what we think we can bring to the table. Through these initial conversations, we’ll work with you to outline potential solutions.

If we both agree that there is a good fit between our companies, the next step is to draft a statement of work (SOW). The SOW document will thoroughly spell out the terms of project engagement and will realistically portray the project.

Because most projects are not entirely defined before the SOW is drafted, the document will be used to define roles, responsibilities, timelines, communication standards, and development methodologies. Project costs and timelines will also be clearly stated.

We Stay Agile

Once the project is underway, an agile methodology will most likely be utilized for the project, requirements, and engineering management.

True Process is a fully engaged agile development shop. In 2013 we made the switch from waterfall to agile, trading our traditional requirements for “user stories” and “use cases.” While agile does require some essential adjustments to run within an FDA-regulated framework, we have found that the agile methodology provides a significant number of advantages. Chief among those advantages is flexibility and speed.

Even in 2018, not everyone is a convert to agile. In truth, most of our medical device customers have been slow to move to agile. Over the years, we have helped these customers understand the value of agile’s flexibility and speed. While we prefer agile, we are always willing and able to work within any company’s development and quality processes.

Regulatory Expertise

One of the biggest concerns for our customers is the need to comply with the regulatory demands of product development. Because we understand these issues, we work hard to make sure this part of the process goes as smoothly as possible.

True Process has a comprehensive ISO 13485-certified quality system in place, tailored specifically for medical software engineering. We understand the process of developing and documenting software that complies with 510(k) premarket submissions. As a part of any project, we’ll help complete a “Design History File” along with thorough project development and testing documentation.

Of course, we are more than happy to work within your established quality system. Having worked with a dozen or more systems in the past, we are quick to adapt to new quality systems.

Expect Specialized Clinical Experience

One strength that separates True Process from other engineering firms is our expertise in clinical environments and connected medical devices. Over the years, we have implemented and integrated more than 200,000 medical devices into hospitals, clinics, and research laboratories. This work has provided us with unmatched insight into how medical devices operate in real-world conditions. We use this expertise to help design software that is well-suited for our increasingly connected clinical environments.

You will also benefit from the experience we have gained by developing our in-house healthcare software products (ViNES, VeriScan). Engineering these products have provided us with peerless expertise in medical device communication, messaging, and interoperability.

Trust and Communications

Throughout the whole process, we work hard to keep you informed of our progress and provide solutions to any technical issues that arise. The agile methodology process helps drive this; daily stand-ups and electronic progress boards offer real-time visibility into team progress.

All projects have challenges, but we work hard to mitigate them. Clients are welcomed and encouraged to participate in our daily status, design review, and retrospective meetings. In the end, we strive for transparency in our processes knowing this will lead to a better engagement experience for our clients.


Using a project-based engineering team can free up your resources; instead of worrying about engineering, quality, and regulatory challenges, you can genuinely focus on product goals. True Process goes the extra mile by providing smart, creative engineering services delivered in a process that ensures quality, timeliness, and cooperation.

Questions? Interested in discussing a possible project? Keep calm and contact True Process today!

Credit: Brick Wall Photo in Blog Illustration by Laura Skinner

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