The 13485 standard is a certification for medical devices. It ensures the safety and effectiveness of products by establishing guidelines for development, design, production, and quality assurance. Thirteen thousand four hundred eighty-five certified medical devices are safer to use because they have been tested extensively before being released on the market. They are also more effective because they utilize innovative technology that has undergone rigorous testing to ensure strict safety and efficacy standards.
– 13485 certified companies spend time designing these devices with end-users in mind
– 13486 compliant companies must be able to demonstrate their capability in meeting or exceeding all requirements
– 13484 compliance assures consumers that these products meet high standards of quality and safety
13485 is a fairly new but very important standard. It means that your product meets the United States Consumer Product Safety Commission (CPSC). This includes having all materials tested to ensure that they meet or exceed regulatory standards.
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