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The U. S. Food and Drug Administration (FDA) has issued Notices of Substantial Equivalence, giving us permission to market our VanishPoint® and Patient Safe® products in interstate commerce. Also, we annually register with the FDA and provide that agency a list of our commercially distributed products.
TUV-USA, a member of the TUV Nord Group, performs our quality management system certification. TUV-USA performs annual surveillance audits to ensure our compliance with EN ISO 13485:2003, CAN/CSA 13485:2003, and Medical Device Directive 93/42/EEC.
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