Medical device manufacturers should comply with ISO 13485 quality standards to launch and market their products without any complications. It is related to a quality management system that is developed to meet customer regulatory requirements. QMS should consist of controlled guidelines and procedures for all procedures. It can help to maintain brand reputation and the customer’s interest. Implementing an extensive quality management system provides many long-term benefits, such as: • Achieve organizational goals • Reduce frequent errors • Improved customer service • Effective marketing • Efficiency business growth • Documentation accessibility • Consistent product quality To ensure these benefits, manufacturers must follow the proper conceptualization and implementation steps for creating a QMS. Define and strategize First, organizations should visualize and define their processes. During this step, they should creat...
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