What Is the Medical Device ISO13485 and How to Certify?

What is ISO13485 certification? It is aimed at the quality management system standards for the medical device industry. It has guiding significance to the establishment of the quality system of the medical device industry. Medical equipment production enterprises and business enterprises can all be certified according to the actual business situation. The basic requirements of the quality management of equipment operation are suitable for all operators engaged in medical device business activities. Medical device business enterprises shall take effective quality control measures in the section of medical device procurement, acceptance, storage, sales, transportation, and after -sales service to ensure the quality and safety of the products during the operation.

ISO13485 is based on the characteristics of medical device production on the basis of ISO9001, and proposes special requirements for pollution, environmental control, risk analysis, and sterilization to ensure the safety and effectiveness of medical devices. ISO13485 is an international standard. From management responsibilities, resource management, product implementation and measurement, analysis and improvement, professional guidance is given to the complete quality management system, but the standard only puts forward some key elements to establish a program for forming files related requirements.

After simply understanding what the medical device is ISO13485 is, many will ask if all companies that operate medical devices need this certification? What is the difference between it?

Medical Device GSP is the basic requirement for operating enterprises, and it is the bottom line of compliant operations in operating enterprises; ISO13485 is not a compulsory standard for medical device business enterprises, so enterprises can conduct comprehensive considerations according to their actual situation. If the medical device business enterprise fails to plan the ISO13485 certification when the GSP system is newly built, it can still learn from the ISO13485 standard in a timely manner.