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	QUALITY SYSTEMS
	FDA developed QSR (Quality System Regulations) which substantially reflects ISO 13485
	Quality system provides a clear path towards achieving the company's vision and its quality objectives and ensures compliance with FDA as well as CE Mark requirements.
	We design, develop, and defend your quality system with FDA as well as Registrars and Notified Bodies. We specialize in addressing the quality and regulatory needs of small businesses by providing the necessary support. They can either avoid the high overheads of permanent staff or reinforce their department whenever needed.


	Mansour Consulting LLC - US FDA and European medical device regulatory consultants Phone: 678-908-8180, Fax: 678-623-3765, info@mansourconsulting.com

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