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Medical Device Software Testing
Be Confident in Your Medical Device Software
Having 17 years of experience with healthcare and 33 years in testing, ScienceSoft helps medical device manufacturers and software providers ensure the quality of medical device software and its compliance with regulatory standards.
Medical device software testing is a way to guarantee the solution’s quality by verifying its requirements and architecture and checking if it meets user needs.
ScienceSoft’s Testing Center of Excellence has accumulated working best practices for testing medical device software. Our team will eagerly implement them to help you smoothly introduce your software to the market or confirm its compliance.
Companies we serve
- Medical device manufacturers.
- Medical device software providers.
- Healthcare providers.
- Pharmaceutical companies.
Medical devices we test
- Class II – medium-risk medical devices (CT scanners, wearable glucose monitors, blood pressure monitors, wearable ECG sensors, etc.).
- Class III – high-risk medical devices (pacemakers, cardioverter-defibrillators, deep-brain stimulators, etc.).
Testing types we excel at
- Functional, including integration and regression testing.
- Usability testing.
- Compatibility testing.
- Performance testing.
- Security testing.
Our testing approaches
We Know the Importance of Thorough Documentation
ScienceSoft understands that you need complete and comprehensive test documentation and provides you with the following deliverables:
- A test plan with clearly identified pass/fail criteria.
- Test cases and automated test scripts.
- Defect descriptions.
- The description of verification and validation activities performed at the API, integration and system levels.
- A system-level test protocol with pass/fail criteria.
- A test results report.
Why Companies Trust Us
- ISO 13485:2016 certified to guarantee testing compliance with the requirements of the FDA and the Council of the European Union.
- ISO 27001 certified to guarantee the security of sensitive information and test data.
- Team with hands-on experience in HIPAA, HITECH and FDA requirements and healthcare data exchange standards (e.g., HL7, ICD-10, CPT, XDS/XDS-I).
- Experience in FDA/CE registration.
- ISTQB-certified test engineers and Doctor of Medicine consultants on board.
-20-40% testing costs
due to:
- KPIs-based testing, tailored to software specifics.
- Reusable test cases.
- Prioritization of testing activities based on the software intended use and risks.
Zero penalties
due to:
- 100% regulatory compliance of medical device software.
- Lack of software-driven malfunctions due to comprehensive testing.
Decreased rate of medical device recalls
due to:
- Result-oriented and thorough testing of your medical device software.
- Complete and comprehensive test documentation.
Having Doubts About Third-Party Testing? Let Us Change Your Mind!
Concern 1: During medical device software testing, there is a risk of disclosing patients’ health information and breaching HIPAA regulations. How can a third-party vendor handle security issues?
During testing projects, we at ScienceSoft apply VPNs, SSL certificates, encryption protocols, etc. The safety of our internal infrastructure is confirmed by ISO 27001 certification.
Concern 2: Will an outsourced testing team be able to swiftly dive into the specifics of our medical device software?
ScienceSoft has multiple successful projects in medical software testing under its belt and guarantees a quick transition. We effectively collaborate with other teams involved in your project so that no business or technical specific gets missed.
Apart from that, ScienceSoft’s testing engineers have working experience with major healthcare regulations (HIPAA, HITECH, ONC, MACRA, MIPS, CEHRT, SAFER) and healthcare data exchange standards (e.g., HL7, ICD-10, CPT, XDS/XDS-I).
Concern 3: Will we be able to track the testing process of our medical device software?
ScienceSoft ensures full transparency over the testing activities, offering detailed reporting and providing test documentation required by ISO 13485 and ISO/IEC/IEEE 29119-3:2021.
Verification & validation
ScienceSoft’s healthcare testing professionals will:
- Verify the quality of medical device software requirements.
- Test medical device software at the API, integration, and system levels.
- Verifying that software architecture is secure.
- Perform software code review and code analysis.
- Run user acceptance testing.
Compliance testing
ScienceSoft’s compliance experts will help ensure medical device software complies with required standards and regulations (e.g., FDA, HIPAA).
Tools We Use to Test Software for Medical Devices
Automated mobile testing tools
Performance testing tools
API testing
Security testing tools
Automated UI testing tools
CI/CD tools
Test management and defect tracking software
Actions Speak Better Than Words: Our Testing Projects for Healthcare
End-to-End Development and Testing of Laboratory Diagnostics Software
In 7 months, ScienceSoft successfully developed, tested, and, as a result, delivered a fully functional CE-marked laboratory diagnostics software. With the newly developed software, the Customer improved client experience with their genetic screening kits and helped their clients ensure test accuracy and fast results interpretation.
Pentesting of a Web Platform and Mobile Apps for a Remote Patient Monitoring Vendor
In 19 days, ScienceSoft performed gray box penetration testing of remote patient monitoring apps, detected several security misconfigurations, and provided an actionable guide with the necessary corrective measures. After the detected security issues were fixed, retesting by ScienceSoft confirmed the platform and mobile apps’ increased security level and compliance with HIPAA of HITRUST CSF.
Web Application Testing for Mobile Nursing Service Provider
ScienceSoft performed functional and regression testing of a web app for mobile nursing services. With the help of ScienceSoft’s testing team, the Customer delivered a fully functioning, comprehensive web application that facilitates mobile nursing providers’ work. The application has been serving stably for 5+ years.
Automated Regression Testing of a Healthcare Solution
ScienceSoft’s automated testing team selected the most important test scenarios, wrote robust automated test scripts, and created a flexible test automation framework. The introduction of test automation helped reduce resources and time for regression testing and, as a result, deliver a high-quality solution on time.
Managed Testing of Health Information Exchange Software for US Healthcare Providers
ScienceSoft ran comprehensive managed testing of HIE software to ensure its smooth and sufficient functionality, proper integration with various EHR systems, compatibility with required web browsers and versions of mobile OSs, and the system’s performance under load.