Software Verification & Validation
Verification & Validation (V&V) for Medical Device Software
At Gener8, our Verification & Validation (V&V) services ensure that your medical, biotech, and life sciences software meets FDA, ISO 13485, ISO 14971, and IEC 62304 regulatory standards while performing reliably in real-world applications.
End-to-End V&V for Regulatory Approval
Achieving FDA compliance requires robust testing and documentation to confirm that software functions as intended. Our dedicated V&V specialists conduct comprehensive verification and validation processes that include:
✔ Regulatory-Compliant Testing –
Full alignment with FDA, ISO 13485, ISO 14971, and IEC 62304 standards
✔ Independent V&V Teams –
Specialists focused solely on functional, performance, and security testing
✔ Risk-Based Validation Strategies –
Tailored validation plans based on software risk classification
Automated & Manual Testing for Maximum Accuracy
We combine automated test frameworks and manual validation to optimize test coverage, accuracy, and efficiency. Our V&V approach ensures:
✔ Functional, performance, and security testing to eliminate defects early
✔ Automated regression testing for faster validation cycles
✔ Comprehensive system verification to confirm compliance and reliability
Proven Approach
Proven Methodology
Proven Performance
Software Tool Validation for Compliance & Integrity
Regulatory bodies require that development tools used in software creation are also validated. We ensure:
✔ Regulatory compliance of development and testing tools
✔ Thorough evaluation of tool functionality and reliability
✔ Clear documentation to support audits and regulatory submissions
Traceability & Documentation for Regulatory Submissions
We provide full traceability from requirements to test execution, ensuring:
✔ Audit-ready documentation that meets FDA and ISO standards
✔ Comprehensive test reports for submission and compliance verification
✔ Seamless alignment between design inputs and intended use
Why Choose Gener8 for Software Verification & Validation?
At Gener8, we take a collaborative and tailored approach to medical software V&V, ensuring:
✅ Expert regulatory knowledge – Deep understanding of FDA, ISO, and IEC requirements
✅ Dedicated V&V specialists – Independent teams focused on verification and validation
✅ Proactive error detection – Minimizing costly fixes and compliance delays
✅ Integrated development support – Working alongside internal and client teams for a smooth process
Ensure Compliance with Proven V&V Strategies
With Gener8’s V&V expertise, your software will meet the highest industry standards, ensuring a
smooth path to approval and market readiness.
Specialized Software Services
At Gener8, we provide tailored software solutions designed for the unique needs of medical devices, life sciences, and biotech industries.
Whether you’re developing a standalone digital health application or embedded software for laboratory instruments, our expertise ensures a seamless
path from concept to regulatory approval.
Instrument Software
SaMD
(Software as a Medical Device)
Cybersecurity
Cloud Solutions
Verification and Validation
QMS
(Quality Management System)
Browse Software Case Studies
Thousands of projects completed.
We’re proud to serve the Biotech, Medical, and Industrial markets.