ISO and FDA Compliance


Meeting and exceeding expectations

BioVision is ISO 13485 and ISO 9001:2000 certified for the design and manufacturing of medical products. In addition, everything BioVision does, from design through post-market surveillance, meets or exceeds the Quality System/Good Manufacturing Practice (QS/GMP) requirements of the United States Food and Drug Administration (FDA). BioVision is registered with the FDA as a medical device manufacturer. We have the systems in place for the “cradle to grave” controls the FDA requires, ensuring that the highest standards are met for medical device quality and safety. For our partners, this translates into rapid, reliable, fully FDA compliant product designs, transitioning to seamless clinical trials and ending with volume manufacturing.



Visualizing better care today; enabling the procedures of tomorrow
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