Documentation Audit

Technical document review and training

Medical devices - Quality management systems - Requirements for regulatory purposes

ISO13485 is an independent standard based on ISO9001, which combines the characteristics of medical device products themselves, and is known as the "requirements for medical device quality management system for regulation". It has more specific applicability and guidance for the medical device industry.

ISO13485 requirements are applicable to the design and development of medical devices, production, storage and distribution, installation, maintenance and final discontinuation and disposal of organizations, the requirements of ISO13485 also apply to suppliers or other external parties that provide products (such as raw materials, components, components, medical devices, sterilization services, calibration services, distribution services, maintenance services) to the above organizations.