Software development for medical devices

  • Reduce manual work during diagnostic procedures with software-enabled medical devices

  • Ensure early diagnostics and risk prevention by adopting digital medical devices

  • Reduce patients’ pain, discomfort, and anxiety with an intelligent medical device ecosystem

  • Increase treatment accuracy and speed using functional software for medical devices

Why choose Yalantis for medical device software development?

  • 9/10

    net promoter score (NPS) among healthcare clients

  • 20+

    software projects for medical devices

  • 10+

    years of experience in healthcare development

  • 100+

    healthcare software development experts

Medical device software engineering solutions from Yalantis

We integrate software into medical devices to enhance their diagnostic, patient monitoring, and therapy capabilities

  • Software for medical devices

    • Development and maintenance of custom medical device software

    • Data retention and interoperability

    • Supplementary infrastructure for medical devices (software gateways, APIs)

  • Software as a medical device (SAMD)

    • Telehealth platforms with remote patient monitoring

    • Treatment software

    • Custom medical imaging software

    • Analytics for processing medical device data

  • Healthcare IT consulting

    • Market analysis to determine the right medical device(s)

    • Consulting on cybersecurity measures

    • Consulting on regulatory compliance

    • Guidance on UI/UX design and business intelligence

  • Quality assurance (QA)

    • Medical device calibration and configuration

    • Precise data collection

    • Supporting high software quality

    • Dedicated QA team for testing medical devices and software

Improve the efficiency of your diagnostics sessions with software-enabled medical devices

Get access to full-cycle medical device software development services, from a thorough consultation on your choice of devices to implementation of a fully established digital medical device network

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Frequently asked questions (FAQ) from our clients

What are medical devices and how are they regulated?

Medical devices are tools, instruments, machines, implants, or other similar products that are intended for use in diagnosing, preventing, monitoring, treating, or alleviating various diseases and health conditions. Medical devices range from simple tools such as tongue depressors to complex machines such as MRI scanners. They are regulated by the Food and Drug Administration (FDA) in the United States, by the European Medicines Agency (EMA) in Europe, and by other regulatory bodies in other countries and regions. 


Obtaining regulatory approval typically involves demonstrating the safety and efficacy of a device through clinical trials and testing procedures. When developing software for medical devices, you must also strictly adhere to regulatory requirements. However, this is difficult to achieve without prior experience in software development for medical devices. Yalantis knows how to ensure a secure development process to help your medical practice operate efficiently and risk-free.

How are medical devices classified and tested for safety and efficiency, and how does this impact the choice of approach to building medical device software?

Medical devices are classified based on the level of risk they can cause for a patient. In the United States, there are three classes of medical devices: Class I, Class II, and Class III. Class I devices are considered low-risk devices such as wearable glucose monitors, Class II are medium-risk devices such as CT scanners, and Class III devices are high-risk devices such as deep-brain stimulators. All medical devices that enter the market must undergo rigorous testing before they can be approved for use. The testing process typically involves laboratory testing, animal testing, and clinical trials. Clinical trials are conducted on people to evaluate a device’s safety and efficacy. 


We offer customized development services depending on the class of the medical device you need to integrate with and for which you need to develop software. The more high-risk the device we have to work with, the stricter the security measures we need to take. Plus, performance and availability requirements will also differ depending on the class of device.

How does medical device software development transform the delivery of healthcare services?

Digital medical devices enable efficient remote patient monitoring, improve clinical decision-making, streamline administrative tasks, and enhance the patient experience and patient engagement. Digital medical devices perform much more accurately than traditional devices, leading to better treatment outcomes. Also, software-enabled medical devices can automate certain tasks that medical staff need to perform manually when using traditional medical devices, such as writing down or printing out patients’ health metrics. With digital medical devices, you can also deliver more personalized patient care thanks to analytics of patient outcomes. As healthcare organizations continue to invest in digital medical devices, we can expect to see further improvements in healthcare service delivery and patient satisfaction.

What is software as a medical device (SaMD), and what SaMD services do you offer at your medical device software development company?

SaMD solutions are intended for use in the diagnosis, treatment, or prevention of a medical condition or disease. These solutions include mobile health apps, clinical decision support software, and other digital health technologies. Software as a medical device differs from traditional medical devices in that it is primarily composed of software code rather than physical components. Additionally, software as a medical device is often designed to be used by patients or healthcare providers in a non-clinical setting. 


Examples of SaMD include mobile health apps for managing chronic conditions, clinical decision support software for diagnosing diseases, and remote patient monitoring systems for tracking patients’ vital signs. Software as a medical device has the potential to improve patient outcomes by providing more personalized and accurate diagnoses and treatments. It can also help healthcare providers manage patient care efficiently and cost-effectively, particularly in remote or underserved areas.

What is your experience integrating healthcare systems with medical devices?

During years of experience developing healthcare products, we’ve worked on numerous projects that involved developing infrastructure for seamless integration with medical devices. We’ve integrated diverse healthcare software systems with all three classes of FDA-approved medical devices.


The Yalantis healthcare team also has experience developing software for medical devices, as some of our clients have needed a solution for displaying data aggregated from these devices. When working with us, the options are vast. You can integrate your existing healthcare systems with medical devices of any class or develop a unique software solution from scratch that integrates with the necessary devices.


We help our clients develop medical device software that speeds up diagnosis and enables accurate remote patient monitoring and chronic disease management.

Do you consult on the choice of medical devices?

If you lack time and resources for analyzing the healthcare technology market to choose the best-fit medical device vendor, we can help. At Yalantis, consulting and development services go hand in hand. Providing all-around technological support is our core responsibility as a trusted development services provider. 


First, we elicit your requirements. Then we start looking for suitable medical devices. If you need to integrate with a smart scale, pedometer, and a blood pressure monitoring device, for instance, we’ll look for a vendor that offers all three medical devices, as it’s much easier to integrate with multiple devices from a single vendor than to work with three separate vendors. When choosing the right medical devices to integrate with medical device software, we pay attention to a vendor’s years on the market, clients’ reviews, compliance with laws and regulations, and data management mechanisms. We usually provide our clients with a few providers to choose from and lay out the benefits of cooperating with each vendor, allowing the client to make the final choice.

How do you handle issues that appear during integration?

Complexities and challenges are common when building medical device software. Mostly, these challenges appear due to lack of sufficient documentation from a medical device vendor or the necessity to integrate a single healthcare solution with many devices from different vendors.


Lack of documentation we can handle either by contacting the vendor’s team and asking them for instructions on how to work with their medical devices or by discussing changing the vendor and integrating with similar devices that have better specifications. When facing challenges with integrating a single healthcare system with several medical devices from different manufacturers, we implement techniques for merging data aggregated from these devices to make sure that your medical device software can seamlessly process data from different devices.


Still, you should keep in mind that each project is unique, and issues can differ and depend on many factors. Even tight development timeframes can cause unexpected issues.

Cybersecurity in medical device software development

Increasing demand for medical device software development services has led to more potential cybersecurity risks. The more complex and interconnected a medical device network is, the more difficult it is to maintain a high level of data protection and the more experienced a technology partner you need. Even a single medical device that isn’t securely connected could pose a threat to the whole hospital network. When looking for a development company, it’s crucial to pay attention to the security measures they implement during the development process and the steps they take to comply with healthcare laws and regulations.

Your potential technology partner should first and foremost prioritize security during the whole development lifecycle, starting from writing code and finishing with releasing that code to the production environment.

To develop secure medical device software, we:

  • integrate a range of security controls including static application security testing (SAST), infrastructure as code (IaC) scanning, dynamic application security testing (DAST), and cloud security audits
  • timely detect and fix software vulnerabilities
  • protect the CI/CD pipeline from pushing vulnerabilities into production
  • enable visibility of application security via insightful dashboards
  • ensure a flexible security ecosystem that can easily scale without lots of workarounds

It’s also important that all stakeholders involved in developing medical device software (developers, quality assurance engineers, and even project managers) have an equal understanding of the cybersecurity process and are aligned to develop a foolproof digital medical device solution. That’s definitely the case with the Yalantis development team. 

Ensuring secure software development for medical devices 

Working with sensitive patient data obtained from medical devices requires implementing robust measures to protect this data under any circumstances. Such measures include encrypting data and implementing strong and reliable access controls. As a healthcare service provider, you can also take your own security measures, such as implementing password policies and training staff on cyber threats and how to prevent them. 

Security measures we implemented when working on healthcare projects   

Here’s an example of how we ensured a high level of security during the medical device software development process for one of our clients:

  • Established SSL-based connection protocols for securely exchanging data between system users and the server
  • Isolated access to the database to enable connections only via the internal network
  • Implemented blocking of suspicious users
  • Integrated a strict password policy
  • Ensured timely detection and prevention of any suspicious activity
  • Added an encrypted communication layer

These security measures helped us establish a reliable security ecosystem for an enterprise healthcare solution and ensure that the product is safe to use, allowing the client to continue spreading their vision of a healthy lifestyle.

Let’s take a look at another medical device project and the specific security precautions we implemented when developing a medical imaging system:

  • Developed a secure private network to enable secure data exchange between hospital facilities and the cloud
  • Ensured that the radiology department’s local server was the only storage location for original medical images
  • Made sure that other software solutions including an electronic health record (EHR) system and central server contained only links to the original medical images

Such measures helped us build an intricate medical device software system for protecting medical images while implementing software interoperability and enabling a smooth exchange of medical images across the whole hospital network. We also developed separate secure hospital infrastructure and cloud infrastructure to split the responsibilities and not overload the local hospital server. The result was that hospital infrastructure was mainly responsible for periphery medical equipment and storing medical images, while cloud infrastructure mainly performed the supportive role of an orchestrational service, a conditional access service, and a media conversion service. In such a manner, we created a distributed high-performance medical imaging system that saves radiologists’ time on diagnostics and eliminates the need for hard-copy medical images. 

Final thoughts on security for medical device software

These projects prove that even though most security mechanisms for healthcare software are rather straightforward, what matters most is how you combine them and implement them into each individual healthcare network. The latter requires experienced guidance and a professional development team. It’s also critical to remember that cybersecurity is an ongoing process that doesn’t end with the software release. You’ll still have to continue performing regular security checks and audits to avoid the risk of patient data breaches. Plus, cyber threats are changing and getting more elaborate with time, requiring security specialists to stay constantly updated on the latest trends and keep their healthcare systems resistant to the latest cyber attacks.

Ensure streamlined healthcare service delivery with custom medical device software

Build functional software to increase the operating speed of your medical devices and help your employees make more accurate clinical decisions

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