Medical Device Manufacturing
Controlled environments play a critical role in ensuring your products meet or exceed quality and regulatory standards. And B&V is here to help ensure these critical environments are delivering as-designed performance in accordance with the exacting standards you require.
From cleanroom certification and clean-air device testing and repair to environmental monitoring and decontamination services, B&V has the range of service offerings, technical expertise and regulatory knowledge to keep you in compliance and up and running.
Contact B&V today to ensure regulatory compliance and peak performance of your controlled environments.
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The FDA is here on a PMA inspection and one of the areas that I had to present to them was the recertification binder for our ISO Class 7 Manufacturing Cleanroom. The auditor provided the following comment during his review: “This is one of the best put-together cleanroom reports I’ve seen”. Please keep up the great work you do for all of our facilities! It’s great to have partners that provide us quality work and are easy to work with too!
Medical Device QA Engineer