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We are the leading Contract Manufacturing Organization (CMO) in the transcatheter heart valve area. We custom produce Transcatheter Aortic Valves (TAVR),...

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Manufacturer shall establish Quality Management System (QMS) and demonstrate compliance before regulatory approvals. Different countries require manufacturers to demonstrate compliance to the regulation that is applicable to that country where the products are intended to be marketed.
https://www.bridgemedsolutions.com/quality-compliance/
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