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Medical Device Software Development

With 5 years in IT and 5 years of experience in healthcare software development, backed up by ISO 13485 and IEC 62304 certifications as well as Microsoft Gold Competencies in application development, Qrapp creates highly secure and reliable software for all types of medical devices.

Medical Software We Develop
Software for medical devices

We know the specifics of the three regulatory classes of medical devices and create failure-proof and HIPAA-compliant software for medical equipment safely used by patients as well as all healthcare professionals, including:

When applicable, we make sure our medical software guarantees:

Software as a Medical Device (SaMD)

We develop software that runs on desktop computers, tablets, and smartphones, assisting patients and healthcare specialists in:

Our Medical Device Software Development Processes

Qrapp offers all-round medical device software development with mature processes that form a seamless workflow in accordance with the stages of a software development life cycle:

Needs elicitation and analysis, requirements gathering and prioritization

We discuss your medical device software concept with you, help you elaborate it and assist with prioritizing requirements.

Specification creation and approval

We transform your requirements into a detailed specification and await your approval before proceeding.

User experience and user interface design

WWe design user-friendly UI for self-explanatory and smooth human-computer interaction.


We implement the functionality of your software in the shortest time possible.

Quality assurance

Our quality assurance (QA) processes go in line with the development to ensure high-grade and fully secure medical device software.

Integration with a medical device

We complete the development by successfully installing software on predesignated medical devices.

Support and evolution (5+ years)

We provide support services and help your software evolve further for as long as you need it.

At our customer’s request, we also provide the following additional services:

Our Medical Software QA

On all stages of medical device software development, we apply OWASP’s S-SDLC (Secure Software Development Life Cycle) practices that involve comprehensive and multi-level quality assurance. We understand that medical device software should be absolutely fault tolerant and therefore must undergo even more rigorous and thorough QA than any other type of software.

Our QA processes in coding:
Our QA processes in testing:
Our QA practices:

As a result of our profound QA processes and practices, we guarantee:

High-quality architecture and code

Flawless user experience

Early prevention and detection of bugs and malfunctions

Medical software product validation according to ISO 13485/IEC 62304

Our Use of Modular Expandable Architecture for Medical Software

At Qrapp, we believe that architecture defines software reliability, expandability, and security. Our software architectures allow adding new modules and even new types of devices with little to absolutely no rework necessary. We achieve this via ensuring system configurability, clear module interfaces, and good encapsulation in every module.

Medical Software Development Service Options

To meet your individual needs, we offer different cooperation models depending on the business type you have as well as the development methodology and the implementation strategy you prefer.

Business type

We welcome all customers and have experience in collaborating with medical device manufacturers, pharmaceutical companies and healthcare software startups.

Development methodology

We apply the development methodology that is beneficial for your project. Regardless of the methodology choice, we guarantee comprehensive and up-to-date documentation, critical for the transparency of the medical software development processes. The methodologies we actively use are:

Why Qrapp?
Our strengths
Some of our customers
Our Approach to Service Delivery

We're a reliable business partner with mature software development processes that are open to audits. We always keep all our activities highly transparent and let you choose the extent to which you want to be involved in the project. Moreover, you can trust the quality of our account management and the competence of our HR department in selecting the best talent.

Let’s Get Started

Whether you need the full-cycle development of medical device software or professional medical device software development consulting, our experienced team of business analysts, developers and QA specialists is at your service. Feel free to drop us a line and get a quote on your concept or request consulting services for your ongoing development project.

See us in action!

We’d love to stay in touch. Describe the digital challenge you’ve faced, and we’ll get back to you with a solution we can offer.