Regulated Software Quality & V&V Engineering
Service · Regulated Software Quality & V&V Engineering
A scoped engagement that closes the gap between your verification evidence and what a notified body expects under IEC 62304: a documented safety classification, a requirements traceability matrix that traces 100% of software requirements to a test, and a V&V plan your quality system can stand behind.
What does the Regulated Software Quality & V&V engagement deliver?
It closes the gap between your verification evidence and what a notified body expects under IEC 62304. The deliverables are a documented safety classification, a traceability matrix tracing 100% of software requirements to a test, and a V&V plan.
A scoped engagement to close the gap between your current verification evidence and what a notified body or auditor actually expects: safety classification, requirements-to-test traceability, and a V&V plan your quality system can stand behind — delivered by engineers who build and operate regulated software themselves, not just advise on it.
What this engagement produces
The IEC 62304 gap assessment and its exported remediation checklist are the starting point, not the deliverable. Under IEC 62304, this service closes the specific gaps that checklist surfaces for MedTech software: a documented safety classification, a working requirements-to-test traceability matrix, and a V&V plan scoped to your software's actual safety class — built by engineers who build and operate their own regulated software products, and have walked through FDA submissions, FedRAMP authorizations, and HIPAA audits directly.
- Risk-Classified
- Safety class (A/B/C) drives required rigor per IEC 62304 §4.3.
- V&V Decoupled
- Verification (built right) evidenced separately from Validation (built the right thing).
- Living Traceability
- Machine-regenerable links from requirements to test executions.
- Audit-Defensible
- Evidence packets structured for direct submission to FDA and Notified Bodies.
Six capability areas
IEC 62304 Software Classification & Gap Remediation
Safety class A/B/C determination grounded in an ISO 14971 risk analysis, with a remediation roadmap for the specific gaps it surfaces.
- Safety Class A/B/C Determination
- Legacy SOUP Evaluation
- Remediation Roadmap
Requirements-to-Test Traceability Matrix
Multi-directional tracing from requirement to design element to test to risk control, regenerated from source control rather than hand-maintained.
- Multi-Directional Requirement Tracing
- Design Control Linkage
- Automated CI-Generated Trace Records
Verification Protocols & Automated Test Harnesses
Unit and integration verification evidence, backed by static code analysis records a reviewer can check against the specification directly.
- Unit Verification Protocols
- Integration Boundary Testing
- Static Code Analysis Evidence
Clinical Validation & Human Factors Evidence
User-needs acceptance criteria and IEC 62366 usability testing protocols, with support through a summative validation study.
- User Needs Acceptance Criteria
- IEC 62366 Usability Testing Protocols
- Summative Study Support
ISO 14971 Risk Management Integration
Risk control verification linked to the specific hazard each one closes, with residual risk reported against the same file the design team uses.
- Hazard Mitigation Verification
- Software Risk Control Option Analysis
- Residual Risk Reports
Audit & Premarket Submission Support
FDA 510(k)/PMA software documentation and Notified Body technical files, plus direct engineering support through the audit itself.
- FDA 510(k)/PMA Software Documentation
- Notified Body Technical Files
- Audit Defense Support
Ready to Build Your Verification Evidence?
Discuss a specific V&V gap, traceability chain, or safety classification.
Engineering services description. Not a quote or a statement of work — scope and pricing are established during the initial consultation referenced from the gap-assessment tool.