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Verification & Validation
Verification answers the question “how do you know it actually happened?”. and Validation answers the question “How do you know it works?”. Both are key to regulatory submissions to show that a product will behave correctly in its intended use environment. We verify that designs meet requirements and validate that the right product was built. The Trace matrix provides assurance that every requirement has been tested.
Learn more about our Capabilities
Our process has been used by clients to successfully move products through the regulatory submission process and ensure product design has met the intended use.
Areas of Expertise:
- Verification and Validation planning
- Input to risk management
- Ensuring requirements are testable
- Writing protocols
- Execution of protocols
- Regression testing
- Writing reports
- Trace matrix
- Formative and Summative studies
The V&V group along with the Systems Engineering team provides full traceability beginning with marketing requirements and through test results, ensuring 100% coverage of requirements. The diagram below describes the process:
Standards-based Design
Some of the design-control standards that we adhere to in our development process are as follows
Quality Management Systems, FDA, EU
Medical Safety Design
- Medical Safety (60601-1, 60601-1-2, 60601-1-8 etc)
- ISO 10993 – Biological
- ISO 11137, 35 – Sterilization
- EN60529 – Ingress protection
Packaging & Labeling
- ASTM D4169 – Shipping Containers
- ASTM D4728 – Random Vibration
- ASTM D5276 – Drop Test
- Various other ASTM standards
- Sterilization
- ISO 15223 – Symbols
- ISO 780 – Packaging graphics
