11/24/2023 0 Comments Iso 13485 2003 pdf![]() ![]() ![]() Along with these, you will need to create the mandatory and additional processes and procedures necessary for your organization to properly create and deliver your product or service. Together, these define the overall scope and implementation of the Quality Management System. Starting with management support and identifying the customer requirements for the QMS, you will need to start developing documentation including the Quality Policy, Quality Objectives, and Quality Manual. ![]() Adopting ISO 13485 provides a practical foundation for manufacturers to address the EU Medical Device Directive (MDD), the EU Medical Device Regulation (MDR), and other regulations, as well as demonstrating a commitment to the safety and quality of medical devices.
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