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Verification and Validation Testing of Medical Device Software
Be 100% Ready for Clinical Validation
In healthcare IT since 2005, ScienceSoft helps deliver patient-safe medical device software fully compliant with healthcare industry standards and regulations.
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Medical device software verification and validation (V&V) testing ensures that software for medical devices and accessories meets its functional and non-functional requirements and fulfills the target users’ needs. It may include integration and regression testing, requirements-based system verification, performance testing, architecture validation, unit testing, code review, and more.
ScienceSoft is ready to provide comprehensive verification and validation testing to help you produce quality and safe medical device software meeting IEC 62304, FDA and other international healthcare regulations
Scope of V&V Testing by ScienceSoft
Companies we assist
- Medical device manufacturers.
- Medical device software providers.
Medical device software we test
We cover all 3 software safety classes as defined by IEC 62304 (requirements to medical device software lifecycle processes):
- Class A – software that cannot cause any injury or damage to health.
- Class B – software that can cause minor harm, such as non-serious injuries.
- Class C – the software that can cause major harm, such as severe injuries or death.
How We Handle the Testing Process
1.
Analysis and planning
We thoroughly analyze the functional and non-functional requirements of medical device software to outline the future verification and validation testing strategy. The amount and granularity of the required testing documentation will depend on the type of medical device software and its safety class.
ScienceSoft’s experienced QA managers create a verification and validation testing plan (together with our in-house healthcare consultants), choose the appropriate testing tools and assemble a project team. The team may consist of QA engineers, developers (e.g., for unit testing, static code analysis), security testers and a compliance consultant.
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2.
Verification & validation testing
Our team conducts verification and validation testing to ensure your software is secure, regulatory-compliant and functions as intended. The scope of software validation and verification testing activities will depend on the software safety class.
Check the most common activities within V&V testing.
- Review of the software functional and non-functional requirements for clarity, consistency, and traceability.
- Checking software architecture and design for unambiguity, security, and compliance with software architecture and design requirements.
- Code review.
- Static code analysis to detect errors early before software is executed.
- Dynamic code analysis to catch the possible performance problems, memory issues, and software crashes during software execution.
- Unit testing. Required for software safety classes B and C.
- Integration testing. Required for software safety classes B and C.
- System testing, including manual or automated functional and non-functional testing (performance, usability, reliability, security testing). Required for software classes A, B and C.
- User acceptance testing.
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3.
Reporting on V&V testing results
In compliance with IEC 62304, we provide detailed and coherent documentation related to verification and validation testing activities:
- A detailed software verification and validation testing plan with the defined acceptance criteria.
- Software requirements, architecture, and design verification reports.
- Software testing plan at the API, integration, and system levels.
- Manual test cases and automated test scripts.
- Test results reports: test execution reports, test summary reports, detailed defects descriptions with root cause analysis, and software performance reports.
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Why Entrust Your Medical Device Software to ScienceSoft
- 34 years in software testing, 18 years in healthcare IT services.
- A solid portfolio of 100+ successful projects for the healthcare IT domain.
- Doctor of Medicine consultants on board.
- Practical experience with HIPAA/GDPR requirements, healthcare data exchange standards (HL7, ICD-10, CPT, XDS/XDS-I), and FDA/CE registration.
- Compliance with ISO 13485 to guarantee medical software testing according to the FDA and the Council of the European Union requirements.
- ISO 27001-certified security management system to ensure full protection of the customers’ data entrusted to us.
- Mature quality management system confirmed by ISO 9001 certification.
Choose Your Service Option
Consulting on V&V testing
ScienceSoft’s QA consultants will design a comprehensive testing strategy, choose testing types, select optimal testing tools to help you deliver quality software and achieve regulatory compliance.
Verification and validation testing
We will test all aspects of your software by running functional, performance, security and compliance testing to make sure your medical device software is ready for clinical validation.
Technologies We Use in Our V&V Testing Projects
Our Featured Healthcare Software Testing Projects
End-to-End Development and Testing of Laboratory Diagnostics Software
In 7 months, ScienceSoft’s team developed a fully functioning lab diagnostics software. During the project, ScienceSoft performed rigorous testing and provided comprehensive documentation that proved software compliance with IVDR, MDR, IEC 62304, ISO 14971, ISO 13485, IEC 82304-1 standards.
Performance Testing of an Injection Management App
In a short time frame, ScienceSoft tested the performance of an injection management application under normal and extreme loads and revealed several bottlenecks. After the issues were eliminated, the application showed stable and smooth performance.
Managed Testing of Health Information Exchange Software
Being responsible for the entire testing project, ScienceSoft’s team performed all-around testing (including role-based access validation) of web and mobile HIE applications and ensured the apps’ functionality, stable performance, proper integration with EHR systems, and user-friendly UX and UI.
Quality Assessment of a Patient Portal
During the assessment, ScienceSoft detected system vulnerabilities, code errors, and poor login protection and provided comprehensive recommendations on how to eliminate them. The implementation of the suggested remediation measures led to tangible quality and security improvements and helped prove the portal’s HIPAA compliance.
Web Application Testing for Mobile Nursing Service Providers
Following the Agile methodology with 2-week sprints, ScienceSoft’s QA engineers conducted in-depth functional testing of a web nursing application, ensuring its smooth operation before each release. As a result, the app has been working stably for 5+ years, facilitating the mobile nursing providers’ work.
Make the Most of Validation & Verification Testing with ScienceSoft
Our clients’ business interests are our primary concern. See how you can benefit from medical device software V&V testing with ScienceSoft:
-20-40% software testing costs due to KPIs-based testing, reusable test documentation and test cases, and optimal prioritization of testing activities.
Easier FDA/CE submission due to exhaustive testing, absence of health-hazard software errors, and comprehensive testing documentation according to ISO 13485 and ISO/IEC/IEEE 29119-3:2021.
Proven protection against data breaches due to professional security and compliance testing.