ISO 13485 is the ideal international quality standard established to provide a complete framework for Medical Devices Quality Management System to minimize risks and ensure the performance of your system, technology and sensitive data.
ISO 13485 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. Such organizations can be involved in one or more stages of the life-cycle, including design and development, production, storage and distribution, installation, or servicing of a medical device and design and development or provision of associated activities
According to the International Organization for Standardization, ISO 13485 applies to companies in one or more stages of medical device production. This includes the sourcing of materials, distribution, design, and sterilization, among other functions in the manufacturing life cycle. Quality management system general requirements, management’s responsibility, documentation standards, and product realization are among the subjects covered in ISO 13485. If an organization can prove conformance to the elements of the quality management system, it can become ISO certified
