Medical Device Verification & Validation Planning
Medical device verification and validation planning is the foundation of a safe product and a successful regulatory submission. At Nometech, we help you define a clear V&V strategy that ensures your testing evidence meets the highest standards, including ISO 13485 and EU MDR.
By aligning your test plans with identified risks and requirements from the start, we help you avoid redundant testing and costly late-stage failures. Consequently, you gain a robust documentation package that supports a smooth regulatory review and builds confidence in your product’s performance.
We plan verification and validation work that supports compliant development and submissions.
Flexible follow-up support
Verification & Validation Planning Support can be provided as a standalone service or combined with follow-up support for test execution, documentation development, or submission preparation as development progresses.
What this includes
We help define a verification and validation approach based on your device type, intended use, risk profile, and target markets. Based on this, the required V&V activities are identified and linked to applicable standards. Evidence requirements are then defined, including how results should be documented and traced.
Our support covers planning for bench testing, software verification, usability validation, and other required validation activities. We align V&V plans with risk management, design inputs, and regulatory documentation to ensure a consistent and review-ready approach.
Outcome
A clear V&V plan and documentation framework that supports credible regulatory submissions, reduces rework, and improves confidence during reviews and assessments.
Not sure if your V&V planning will meet regulatory expectations?
We can review your plans and help identify evidence gaps and priorities.