Author：MeCan Medical–ultrasound machine manufacturers
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.