Medical Device Software Development
With 31 years in IT and 15 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.
Medical Software We Develop
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.
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:
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Needs elicitation and analysis, requirements gathering and prioritizationWe discuss your medical device software concept with you, help you elaborate it and assist with prioritizing requirements. |
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Specification creation and approvalWe transform your requirements into a detailed specification and await your approval before proceeding. |
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User experience and user interface designWe design user-friendly UI for self-explanatory and smooth human-computer interaction. |
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DevelopmentWe implement the functionality of your software in the shortest time possible. |
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Quality assuranceOur quality assurance (QA) processes go in line with the development to ensure high-grade and fully secure medical device software. |
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Integration with a medical deviceWe complete the development by successfully installing software on predesignated medical devices. |
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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.
- Well-structured, documented code
- Unit testing
- Regular code reviews
- Test planning
- Continuous testing during development
- Release testing (in case of iterative development)
- 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:
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High-quality architecture and code |
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Flawless user experience |
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Early prevention and detection of bugs and malfunctions |
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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.
We welcome all customers and have experience in collaborating with medical device manufacturers, pharmaceutical companies and healthcare software startups.
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)
- 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
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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.