First FDA Inspection passed with ZERO Observations

BAAT Medical has an Establishment Registration & Multiple Device Listings at the FDA and has successfully passed their first FDA inspection, on compliance with our quality system regulation and good manufacturing practice, with zero observations.

This outstanding result reflects the strength of our lean yet mature Quality Management System, supported by an excellent documentation framework and a highly experienced team.

Thanks to this foundation, every request and question from the inspector could be addressed within minutes, ensuring a smooth and controlled inspection process.

At BAAT Medical, we combine regulatory and quality excellence with engineering expertise, enabling us to support our partners in bringing safe, effective, and innovative medical devices to the global market.

Would you like to know more on how we can support you?

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