Medisono LLC., will consistently provide products and services that meet the requirements and expectations of our customers while complying with legal and regulatory requirements. We will maintain the effectiveness of our QMS by actively pursuing ever improving quality through programs that enable each employee to do their job right the first time and every time.
The quality assurance management system that supports the design, development, manufacture, assembly, testing and release of Medisono products is comprehensive, robust and meets the requirements of both regulatory agencies and customers.
Medisono QMS is certified by international quality system standards including ISO 13485 and ISO 9001
• The components used to manufacture Medisono products meet the requirements of the quality system acceptance activities (inspection and test).
• Delivered Medisono products meet the requirements of the quality system acceptance activities (inspection, test and traceability).
Medisono products are designed, manufactured, assembled, and distributed in full accordance with the requirements of domestic and international laws and regulations.
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All Medisono products are FDA certified
Medisono products meet the applicable requirements of the European Medical Device Directive (MDD) and are therefore CE marked prior to being placed on the market.