▌   ISO13485 certification

ISO13485 stands for "Quality Management System for Medical Devices". This standard was developed by ISO/TC 210-Quality Management and General Requirements Standardization Technical Committee for Medical Devices. It covers every link in the entire life cycle of medical devices, including product establishment, design and development, sample preparation, registration testing, clinical trials, product registration, production, sales, and use. Compliance with IS013485 enables manufacturers to clearly demonstrate their ability to provide medical device products that continuously meet customer requirements and applicable regulatory requirements, providing confidence for consumers and professionals.

Medical device certification is equally applicable to brand owners, small manufacturers, and multinational companies.

▌   Scope of ISO13485 certification

This standard applies to organizations that design and develop, produce, store and distribute, install, maintain and ultimately decommission and dispose of medical devices, and to suppliers or others that provide products (e.g. raw materials, parts, components, medical devices, sterilization services, calibration services, distribution services, maintenance services) to the above organizations.

▌   Benefits of ISO13485 Certification

√Authoritative quality certification

When bidding for international contracts or expanding new business, the ISO13485 certification will be able to prove that you have a high-level medical device quality management system.

√ Improve overall performance

Prove that you continue to meet market demands in terms of product quality, customer satisfaction and continuous improvement, and significantly improve the overall performance of your company.

√Win the trust of customers

Obtaining this certificate proves that your medical products, equipment and accessories are of high quality and have reliable quality control guarantees, thus winning the trust of customers.