The Double Meaning of Validation

Understanding Validation in Medical Devices: A Consulting Insight

It's interesting what you can discover when you expand your network beyond your usual circle. I've been in the medical device industry for 23 years, so the term "validation" has always had a specific FDA regulatory meaning for me. However, for those unfamiliar with the industry, the term can mean something entirely different. Now, when introducing myself, I've learned to start by saying that I specialize in qualifying equipment for life sciences companies. Only then do I mention the term "validation", to avoid any confusion with therapy. Any discussions resembling therapy that I've had in my role as a validation manager were purely coincidental.

Don't let the double meaning of validation trip you up. Reach out to Brayearst Validation Consulting for clarity and compliance in your validation processes.


About Brayearst Validation Consulting

Brayearst Validation Consulting leverages Six Sigma methodologies to provide targeted validation services for the life sciences industry. We specialize in process, cleaning, software, and analytical test method validation, ensuring compliance with FDA requirements while optimizing operations for efficiency and quality. Our team combines technical expertise with a deep understanding of regulatory standards to deliver process-driven validation documents that withstand rigorous auditor scrutiny. From strategy development to study execution, we empower our clients to achieve operational excellence and bring high-quality products to the market with confidence.

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The Knob That Changed Everything