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Verification (n.) | proof…

Confusion abounds about the difference between medical device verification and validation. The short answer: Verification is the process of proving that a medical device matches what was designed—before it is tested out in the real world (validation). Not only must the design output match the design input, but each and every component must match design specifications, as well. That means you need precise testing protocols specific to your device and components, people who know how to carry them out, and, at times, special tools and equipment. It’s a specialized skill set that may be outside of your expertise.

…of perfectionism

The good news is that verification can help ensure a near-perfect design and near-perfect product. The FDA requires every facet of the process be documented as part of your design history file (DHF)—including how tests were conducted, when, and by whom.

No matter where you are in the verification process or how much (or how little) help you need, AlvaMed can work with you in the ways that work for you. We have the tools, equipment, and know-how to write protocols, train your people, perform the tests, and prepare comprehensive, compliant reports that are relevant to your design input. You’ll even gain some valuable knowledge in the process. Want to know more about verification vs. validation? Contact AlvaMed. Find out how we take the “test” out of verification testing.

Click here to begin a conversation or call 781-710-2418.

Email us at info@alvamed.com.

Learn more about:
AlvaMed Quality Assurance
Design Control
Quality Systems
Risk Management
Validation

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