Medical Device Software Development

Medical Device Software Development - ScienceSoft

Medical device software development services comprise specification creation, software coding and testing, integration with a device, and more. ISO 13485 certification and 16 years of healthcare IT experience back up ScienceSoft’s skills in creating secure software for medical devices and SaMD.

Need to Develop Safe Medical Device Software?

ScienceSoft is ready to take over full-cycle medical device software development, help comply with applicable regulations and assist with product registration.

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:

  • Physicians.
  • Nurses.
  • Surgeons.
  • Lab assistants and technicians.

When applicable, we make sure our medical software guarantees:

  • Communication with your IoMT system.
  • Comprehensive data analytics.
  • Integration with EHR, ADT, and other software via HL7 v.3 or FHIR.
  • Gathering of Patient-Generated Health Data (PGHD).

Software as a Medical Device (SaMD)

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

  • Treatment planning.
  • Medical image viewing.
  • Image recognition.
  • Heart-rate monitoring.
  • Drug dosage calculating, etc.

Our Medical Device Software Development Processes

ScienceSoft 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


Specification creation and approval


User experience and user interface design




Quality assurance


Integration with a medical device


Support and evolution (5+ years)


If required

During our cooperation, ScienceSoft proved to have vast expertise in Healthcare and Life Science industries related to development of a desktop software connected to laboratory equipment, mobile application and data analytics platform. They bring top quality talents and deep knowledge of IT technologies and approaches in accordance with ISO13485 and IEC62304 standards.

Sergey Shleev, Prof. Dr. Department of Biomedical Science, Malmö University

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

  • Well-structured, documented code.
  • Unit testing.
  • Regular code reviews.

Our QA processes in testing

  • Test planning.
  • Continuous testing during development.
  • Release testing (in case of iterative development).

Our QA practices

  • Modular architecture – for easier software maintenance and evolution.
  • Risk-based testing – full test coverage for critical code parts.
  • Extensive automation – for increased test coverage without regression errors, accelerated delivery, reduced costs.
  • Exploratory testing – to find defects in projects with incomplete requirements or tight deadlines.

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

Benefits - UX

High-quality architecture and code.

Benefits - UX

Flawless user experience.

Benefits - UX

Early prevention and detection of bugs and malfunctions.

Benefits - UX

Medical software product validation according to ISO 13485/IEC 62304.

Our Use of Modular Expandable Architecture for Medical Software

At ScienceSoft, 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:

  • Waterfall.
  • Iterative (including RUP and Agile).

Implementation strategy

  • One version – we fulfill all the requirements for your medical software product during one development life cycle and deliver a full-fledged version of the product as a result.
  • Multiple releases – we apply the iterative approach when it suits your project. By implementing the basis for your software first, we deliver a reliably functional product early on. Then, working closely with your product team, we gradually evolve the software by adding new features and completing release testing on each iteration (every 2-4 weeks). Our focus is always on preserving high-quality of each new version of your software product.

Why ScienceSoft?

Our strengths


  • 32 years in the global IT market and 16 years in healthcare.
  • ISO 13485:2016 certification proving compliant quality management system for medical devices and software as a medical device (SaMD).
  • Knowledge of healthcare standards (HL7, ICD-10, CPT, XDS/XDS-I, etc.)
  • 100+ healthcare projects.
  • A proven track record of FDA/CE certifications.
  • Experience in software product development.
  • 8 Gold Microsoft Competencies.
  • Recognitions from BBB (rating: A+), Forrester, and
  • Conformity with certified development practices alongside a deep understanding of individual user needs.
  • Integration of medical software with big data, IoT, image analysis, blockchain, and other innovative technologies.
Remote Care Application Development

Remote Care Application Development

ScienceSoft developed Android and iOS apps to collect and analyze medical data from Bluetooth sensors and enable patients to communicate with medical staff. A web dashboard accompanied the mobile apps to monitor patients' state.

Development of a Mobile Baby Care App for a Smart Baby Care System

Development of a Mobile Baby Care App for a Smart Baby Care System

ScienceSoft developed a baby care app for iOS and Android that connects to the Customer’s 5 branded devices and allows remote control and automatic data collection.

Mobile Heart Rate Tracking App Development

Mobile Heart Rate Tracking App Development

ScienceSoft delivered an app that helped collect data from the connected heart rate monitor and assess a user’s physical fitness. The iOS app analyzes parameters collected by the monitor during 3-4-minute physical tests and presents the results in a three-colored chart.

Development of Point-of-Care Testing Software for a Global Healthcare Software Provider

Development of Point-of-Care Testing Software for a Global Healthcare Software Provider

ScienceSoft has developed a point-of-care testing tool that guides through the whole process of medical device quality assurance.

Development of Brain Tumor Localization Application

Development of Brain Tumor Localization Application

ScienceSoft created an application based on a convolutional neural network (CNN) to analyze MRI brain scans. The algorithms allow automated brain cancer diagnostics and tissue type definition with 87% accuracy.

Development of X-ray Imaging Quality Management Software and Datacenter

Development of X-ray Imaging Quality Management Software and Datacenter

ScienceSoft developed software analyzing quality issues in X-ray images. The system stores and processes medical images to help detect troublesome areas: inadequate actions of a technologist, patient-related difficulties, equipment malfunctions, or process deficiencies.

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.

Get Started with Your Medical Device Software Project!

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.