Digital Health

Medical device software development


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Experts in building HIPAA-compliant software for medical devices

Validation and verification

We thoroughly validate and verify the software through testing and simulation to ensure that it functions as intended and meets safety and performance requirements.

Usability engineering

We make sure that our solutions are safe, reliable, and user-friendly through human factors engineering, usability testing, and UX research. Meeting user requirements is our priority.

Utility and scalability

Our products are designed to meet your specific needs while maintaining Our role doesn't end with your product's launch; we also ensure its longevity. We will provide periodic updates and patches to keep your solution up-to-date and optimized.

Regulatory compliance

Medical device software is subject to strict regulations. Our devs possess a full understanding of these regulations and ensure that our solutions comply with all applicable requirements.

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Discover how Health Folder revolutionizes medical documentation management with its AI-powered mobile app built using low code.

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Our digital health software development process

This is how we work



  • Budget Consulting
  • Strategy Consulting
  • Product Discovery Workshop

Discover & Define

  • UX Research
  • Product Roadmap
  • UX Design
  • UI Design

Deliver & Scale

  • Product Development
  • DevOps Architecture
  • Continuous User Feedback & Delivery


  • Recruit your own team with our help

Medical Device Software FAQ

Everything you need to know about medical device software and its development.

What are smart medical devices?

Smart medical devices are medical devices that use software and communication technologies to collect, store, and transmit data. This data can be used to monitor patients' health, diagnose diseases, and deliver treatments. Examples of smart medical devices include wearable fitness trackers, continuous glucose monitors, and insulin pumps.

Can you design software for medical devices?

Yes, we can! Our team of experienced engineers, UX specialists, and product owners has the skills and expertise to develop solutions for a wide range of smart medical devices. We work closely with our clients to understand their specific requirements and develop products that meet those needs.

When we design and build medical device software, we focus on safety, reliability, and performance. We use a rigorous product development process that ensures our medical device software meets all applicable standards and regulations.

What is software validation in medical devices?

Software validation in medical devices is the process of ensuring that software meets its intended use requirements and is safe and effective. We employ a variety of software validation techniques, including testing, analysis, and verification.

What's your approach to software testing?

Our medical device software testing process includes unit testing, integration testing, system testing, and acceptance testing. We also employ risk-based testing to concentrate our efforts on the most critical areas of the software.

At Pragmatic Coders, we prioritize internal testing, making sure that all our developers are proficient in conducting rigorous validations.

What is the standard for medical device software?

The standard for medical device software is the International Organization for Standardization (ISO) 13485:2016 standard. This standard provides requirements for the quality management system of medical device manufacturers.

Can you integrate AI into medical devices?

Yes, we can. We have experience in integrating a variety of AI technologies, such as machine learning, and computer vision. We can use AI to improve the accuracy and efficiency of medical devices, as well as to develop new features and capabilities.

Can you do other medical device integrations?

Yes, we can do medical device integrations. We have experience integrating medical devices with a variety of systems, including hospital information systems, electronic health records systems, and telemedicine systems.

Can software be a medical device?

Yes, software can be a medical device if it is intended to be used for a medical purpose. Examples of software as medical devices include mobile apps that monitor patients' health and software that controls implantable medical devices.

Examples of such software are:

  • Mobile app that monitors patients' blood glucose levels
  • Software that controls an insulin pump
  • Software that analyzes medical images
  • Software that provides treatment recommendations to doctors

A tremendous value that Pragmatic Coders brings to the table is that when we submit a user story, they don’t just take it and start working on it. They conduct a comprehensive internal review of the user story and come back with questions that push us to think of aspects that we didn’t consider. They really challenge us so that we don’t miss any requirements or make assumptions in our user stories.

Our other healthcare software services

E-prescribing Software Development
E-prescribing Software Development
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Care Management Software Solutions
Care Management Software Solutions
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Telemedicine Software Development Company
Telemedicine Software Development Company
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Pharmacy Management Software Development
Pharmacy Management Software Development
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Patient Portal Development
Patient Portal Development
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Wearable App Development Company
Wearable App Development Company
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Medical Imaging Software Development
Medical Imaging Software Development
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Patient Engagement Apps Development
Patient Engagement Apps Development
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Medical Practice Management Software Development
Medical Practice Management Software Development
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Telehealth App Development Company
Telehealth App Development Company
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Custom Physical Therapy Apps
Custom Physical Therapy Apps
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Let's talk

We’ve got answers on anything connected with software development.

Ask a question

You can ask us a question using the form below. We will respond as soon as possible.

Schedule a meeting

You can also schedule an online meeting with Wojciech, our Senior Business Consultant.

wojciech knizewski portrait
Wojciech Kniżewski

Senior Business Consultant

8 out of 10

founders who contacted us wanted
to work with our team.

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