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.
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 software we test
We cover all 3 software safety classes as defined by IEC 62304 (requirements to medical device software lifecycle processes):
- Class C – the software that can cause major harm, such as severe injuries or death.
How We Handle the Testing Process
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.
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.
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.
Why Entrust Your Medical Device Software to ScienceSoft
See What Our Customers Value in ScienceSoft’s Approach
President & CEO
I am particularly impressed by the cooperative nature of ScienceSoft’s team. ScienceSoft has been a competent partner for medical software development. We would recommend them as a trustworthy vendor. They are reliable, thorough, smart, available, extremely good communicators and very friendly. We would recommend hiring ScienceSoft to anyone looking for a highly productive and solution-driven team. We look forward to working with them over the long-term.
The cooperation was a result of a vendor competition where the focus was not only on quantity of testing, but very much on quality and the communication with the testers. ScienceSoft came out as the clear winner. We have worked with the team in very close cooperation ever since and value the professional as well as flexible attitude towards testing. We hope to continue our cooperation into the future expect to grow the business as our customer base also grows, which is a direct result of the higher quality standards that ScienceSoft helps us to achieve.
During the project, we were impressed by their code analysis proficiency and in-depth knowledge of telemedicine specifics. We are thankful for the meticulous and value-driven approach of ScienceSoft’s team. ScienceSoft’s project manager, business analyst, QA and software engineers were always friendly and ready to answer our questions or solve any ad-hoc issues. ScienceSoft proved to be a reliable vendor with a solid healthcare background, and we recommend them to everyone looking for a telehealth software development partner.
Choose Your Service Option
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: