Medical Device Software Development

Medical Device Software Development

With 30 years in IT and 14 years of experience in healthcare software development, backed up by ISO 13485 and IEC 62304 certifications as well as Microsoft Gold Competencies in application development, ScienceSoft creates highly secure and reliable software for all types of medical devices.

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Medical Software We Develop

Software for medical devices

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 solutions 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.

Software as a Medical Device (SaMD)

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

Needs elicitation and analysis, requirements gathering and prioritization

We discuss your medical device software concept with you, help you elaborate it and assist with prioritizing requirements.

Specification creation and approval

Specification creation and approval

We transform your requirements into a detailed specification and await your approval before proceeding.

User experience and user interface design

User experience and user interface design

We design user-friendly UI for self-explanatory and smooth human-computer interaction.

Development

Development

We implement the functionality of your software in the shortest time possible.

Quality assurance

Quality assurance

Our quality assurance (QA) processes go in line with the development to ensure high-grade and fully secure medical device software.

Integration with a medical device

Integration with a medical device

We complete the development by successfully installing software on predesignated medical devices.

Support and evolution

Support and evolution (5+ years)

We provide support services and help your software evolve further for as long as you need it.

At our customer’s request, we also provide the following additional services:

  • Integration with IoMT and healthcare systems (EHR, LIMS/LIS, PACS, etc.).
  • Application for FDA certification and/or CE marking.
  • Help desk services.

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 – to enable easier software maintenance and its further evolution.
  • Risk-based testing (RBT) – to maximize test coverage of the most critical code parts.
  • Extensive automation – to increase testing coverage and eliminate regression errors as well as to accelerate delivery, reducing testing 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:

Code

High-quality architecture and code

User experience

Flawless user experience

Bug

Early prevention and detection of bugs and malfunctions

Validation

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

Business type

We welcome all customers and have experience in collaborating with medical device manufacturers, pharmaceutical companies and healthcare software startups.

Development methodology

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

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

Our partners

  • 30 years in the global IT market and 14 years in healthcare.
  • ISO 13485:2016 and IEC 62304:2006 certified.
  • 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.
  • 6 Gold Microsoft Competencies.
  • Recognitions from BBB (rating: A+), Forrester, and Clutch.co.
  • 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.

Some of our customers

  • A global S&P 500 producer of laboratory equipment.
  • A US research facility working with military forces and healthcare/sports organizations.
  • An Asian technology-driven biomedical research center.
  • A Swiss medical device software manufacturer.
  • A German supplier of medical devices.

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.

Let’s Get Started

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. Feel free to drop us a line and get a quote on your concept or request consulting services for your ongoing development project.

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