Medical device software development services

Medical device software development services

Whom we serve

Itransition handles a full software development life cycle, including design, implementation, and technical support services for care providers, medical equipment manufacturers, and healthcare startups. We strictly adhere to medical device industry requirements for the healthcare software development process, ensuring user safety and data protection.

We develop solutions for

Blood banks

Research centers

Pharmacies

Medical education providers

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

In-home usage

Hospitals

Laboratories

Looking for software tailored to your medical device?

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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 FHIR and DICOM standards

Our services

Consulting

We assess your organization’s requirements and equipment to choose the best-fitting software type and elaborate the project implementation plan.

Implementation

Our development team will create custom medical device software according to your organization’s and regulatory requirements and implement it into your healthcare IT ecosystem.

Integration

We will integrate medical device software with other software solutions or third-party tools (e.g., native software in particular medical equipment).

Maintenance & support

Our support team will help you solve any upcoming issues with your medical device software, continually monitor its performance, and implement updates if needed.

Types of software solutions we implement

Our development team delivers stand-alone software as a medical device (SaMD), as well as software for medical devices for in-hospital, in-home, and on-body usage. Our custom software created according to medical device regulations enables real-time monitoring and management of the devices, helps to collect and analyze health data coming from them, and enables their integration with other peripheral smart devices: e.g. barcode scanners, biometric and RFID readers, temperature, humidity and cardiac sensors, scales, smart pens, tubing welders, etc.

In-hospital

  • Smart carts
  • Blood collection devices
  • Medical imaging solutions

In-home

  • Inhalers
  • Voice assistants
  • Baby care
  • Thermometers

On-body

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

Our success case studies

Blood collection device software

100

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

3

component solution

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

Medical IoT for emergency care

Multi-tenant

HIPAA- and FDA-compliant solution

We developed a solution enhancing the quality of patient treatment during the Code Blue event and enabling inventory management in resuscitation carts.

IoT device management software

50,000+

potential users

Our team delivered an iOS application that enables remote management of connected humidifiers and serves as a solid foundation for further development of the customer’s planned IoT ecosystem.

Blood collection device software

100

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

3

component solution

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

Medical IoT for emergency care

Multi-tenant

HIPAA- and FDA-compliant solution

We developed a solution enhancing the quality of patient treatment during the Code Blue event and enabling inventory management in resuscitation carts.

IoT device management software

50,000+

potential users

Our team delivered an iOS application that enables remote management of connected humidifiers and serves as a solid foundation for further development of the customer’s planned IoT ecosystem.

Blood collection device software

100

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

3

component solution

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

Medical IoT for emergency care

Multi-tenant

HIPAA- and FDA-compliant solution

We developed a solution enhancing the quality of patient treatment during the Code Blue event and enabling inventory management in resuscitation carts.

IoT device management software

50,000+

potential users

Our team delivered an iOS application that enables remote management of connected humidifiers and serves as a solid foundation for further development of the customer’s planned IoT ecosystem.

What our clients say

We were able to rely on Itransition’s expertise, granting them a high level of freedom in decision-making and being open to their ideas. By working in close correlation with us, they always strived to think through the most viable and innovative implementation option, while bearing in mind both the delivery terms and the financial aspects of the project. Therefore, we unreservedly recommend Itransition as a reliable and valuable technology partner, able to deliver complex and innovative solutions of any scale and within the shortest timeframe.

Brian Shoenfeld

Brian Shoenfeld

Chief Executive Officer, Nuvara

For more than 8 years, Itransition is the technical development partner for the Terumo BCT product, and has a proven track record. Itransition is one of the top development partners for Terumo BCT. Although located relatively far away from each other, the communication between the Terumo BCT Leuven office and Itransition happens very fluently. We would like to thank Itansition for its continued efforts to make innovative products together.

Wilfried Mertens

Wilfried Mertens

I&D Director EMEA, Japan & India, Terumo BCT

Areas of application for medical device software

Areas of application for medical device software

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

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 mobile apps and updating their health records on the go.

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.

Custom medical device software we develop helps to measure the minuscule as well as large quantities of any substance with high precision. It also allows for effective compound analysis, enabling medication quality control.

Our solutions’ functionality can simplify inventory management, resource tracking and optimization at healthcare facilities. SaMDs also help satisfy specific requirements for 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.

We develop multiple types of 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).

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Advanced technologies for medical devices software development

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

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 spent 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 & 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

1

Requirements gathering & specification approval

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

2

Planning & UX/UI design

Our developers prepare the project roadmap and the solution’s technical documentation, while the UX design team builds a comprehensive user interface and ensures a positive user experience.

3

Medical device software development

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

4

QA & 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 and GDPR compliance audits.

5

Support & upgrade

On demand, our team provides not only medical device software development services but also risk management and 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 vendors, 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 engineering?

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?