Medical device software development

Medical device software development

We deliver custom software for medical devices, fully compliant with all healthcare regulations to help streamline workflows, make data-based clinical decisions, provide timely personalized care, enhance diagnostic precision, and enable patients to be more proactive in their health management.

Whom we serve

As an experienced medical device software company, Itransition provides design, implementation, and technical support services for a wide range of devices. We strictly adhere to regional requirements for healthcare software development, ensuring user safety and data protection.

We develop solutions for

Blood banks

Research centers


Medical education providers

Other types of care facilities (hospices, nursing homes, etc.)

In-home usage



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Why choose Itransition for medical device app development

25+ years of experience in healthcare IT

Compliance with IEC 62304, HIPAA, and FDA (including FDA 21 CFR Part 820, FDA 21 CFR Part 11)

Working experience with FDA classes II and III, and IEC 62304 classes A, B and C of medical devices

Adequate knowledge of​​ ICD-10 and CPT codification, as well as DICOM standards

Types of medical device software solutions we implement

We create SaMD for in-hospital, in-home, and on-body usage. Our custom software manages and monitors medical devices, collects and analyzes medical data coming from them, and enables their integration with other peripheral, devices: e.g. barcode scanners, biometric and RFID readers, temperature, humidity and cardiac sensors, scales, smart pens, tubing welders, etc.


  • Smart carts
  • Blood collection devices
  • Image analysis


  • Inhalers
  • Voice assistants
  • Baby care
  • Thermometers


  • Smart watches
  • Fitness trackers
  • Blood pressure and heart rate monitors
  • Glucometers
  • Insulin pumps

Areas of application for medical device software

Areas of application for medical device software

Remote care

Our solutions help ensure high-quality remote patient monitoring and consulting. Connected to sensors, these applications continuously measure health parameters and transmit the data to be immediately synchronized with relevant clinical systems for the clinician’s review.

Patient self-service

SaMD lets users monitor their lifestyle, sleep, nutrition, and mental health. They gain more control over their own health by managing their medical gadgets via smartphone and updating their health records on the go.

Diagnostic and treatment assistance

We employ advanced technologies while developing software to make medical procedures faster, more precise, easier to perform for the medical professionals, and more comfortable for the patients. Our solutions allow diagnostic manipulations to be streamlined as well, enhancing the accuracy of particular tests (e.g. blood tests, MRI or CT scans, X-rays) and overall diagnosis.

Mass measurement and analysis

SaMD performs the measurement of the minuscule as well as large quantities of any substance with high precision. It also allows for effective compound analysis, enabling medication quality control.

Facilities monitoring and management

Our solutions can simplify inventory management, resource tracking and optimization at healthcare facilities. SaMDs also help ensure the air and water quality in a building, alert responsible parties in case of in-hospital infection outburst, keep the needed temperature balance, and perform other environment and equipment checks that are crucial for patient and personnel safety.

Medication management

We develop software that helps ensure timely, safe and accurate administration of medications to the patients (e.g. automated reminders, medication pumps, adverse reaction trackers, drug interaction trackers), and also supports proper medication storage, discharge, and disposal (e.g. storage conditions monitoring solutions).

Our medical device integration services

Creating an ecosystem of seamlessly connected devices and software helps healthcare organizations boost their productivity. Itransition serves as a medical device integration company to ensure easy and secure flow of data through all your systems.



Medical device integration with EMR or EHR lets you upgrade patient information stored in the system automatically based on the data received directly from medical devices or analytical insights about patient condition changes.

Hospital management software

This integration allows you to take a step toward an automated smart hospital, streamline some of the routine tasks, and control all your medical devices from one system.

Pharmacy management software

Through the integration with PMS, hospitals can dispatch medications automatically and prevent adverse reactions by gathering and analyzing information from patients’ medical devices.



Allow medical professionals to conduct full-scale online consultations by enabling remote examination, diagnostics, and treatment through medical device software integration with telecare.

Expand your healthcare service offering with connected care technology

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Our success stories

Blood collection device software


blood centers use our solution

Our experts developed an FDA and IEC 62304-compliant web solution to optimize blood data collection and management and streamline device operation and monitoring.

An asthma management app suite


component solution

We created a suite of connected solutions for asthma management by patients and clinicians, complemented with a user management platform.

Baby care IoT R&D


vendors over the world coordinated

Baby care IoT R&D

Itransition’s IoT specialists conducted research, developed the ecosystem architecture, and offered technological guidance in a smartification project for a baby care devices manufacturer.

Automated testing for a medical IT frontrunner


test cases implemented

Automated testing for a medical IT frontrunner

Our QA team developed a comprehensive automated test suite based on the customer’s manual test cases and product requirements, ensuring their FDA compliance and a triple reduction in testing costs.

Advanced technologies for medical devices software development

We combine our medical device software development expertise with innovative technologies know-how to to help healthcare companies expand the scope of their medical devices’ capabilities.

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Benefits of custom medical device application development

Better patient outcomes

SaMD can help make patients more aware of their health status and enable them to manage it more successfully, reduce man-made mistakes, and enhance the accuracy of diagnostics.

Reduced cost of care

Automating medical procedures with smart gadgets and apps reduces the time and effort spend on these tasks, allowing hospitals to allocate human resources for other more urgent activities. Additionally, since SaMD can reduce the number of hospitalizations, healthcare organizations need less physical space.

Enhanced patient engagement and loyalty

Patients are generally more satisfied when given more control over their health or provided a high-quality service. SaMD lets care providers achieve both, making patients feel more positive about their medical organization, which makes them more likely to participate in surveys and research, purchase new services, and stay with their provider.

New business opportunities

Smart software design for medical devices help organizations to optimize resources, which can be directed to developing new business opportunities. Equipped with innovative technology, medical businesses can attract new patient groups and offer new types of services.

Data safety

Medical device software design that complies with the most recent regional regulations ensures safe gathering, storage, transfer and removal of sensitive data, more resilient to human mistakes and ransomware attacks, and prevents data breaches and accidental leaks.

Our medical device software engineering process


Requirements gathering and specification approval

Our team works closely with your representatives to understand your current needs, access the requirements, and come up first with a concept and later a detailed specification of the future medical device software.


Planning and UX/UI design

Our developers prepare project roadmap and the solution’s technical documentation, while the UX/UI team designs the software’s comprehensive user experience and interface.


Medical device software development

Our experts develop cross-platform software that is easy to integrate with already existing systems according to major healthcare industry requirements.


QA and testing

We continuously test your software during development and follow practices that involve multi-level quality assurance. We also make sure to provide comprehensive documentation for easier FDA registration or HIPAA compliance audits.


Support and upgrade

On demand, our team provides not only medical device software development services but also support services, monitoring the software performance, resolving upcoming issues, and delivering the needed upgrades.

Frequently asked questions

While choosing among SaMD developers and medical device integration companies, it’s important to know as much as possible about the specifics of the vendor’s services. To make things easier for you, we’ve answered the questions frequently asked from us.

What technologies do you use for medical device software development?

What cooperation models do you offer?

How much does it cost to develop software for medical devices?

Do we need to have a real device for SaMD software development?