3. Different focus: GMP pays most attention to the substantive details. 13485 is just a general standard. The specific implementation level depends on the internal situation of the enterprise.
4. GMP supervision auditors are all uncles. 13485 auditors act based on the face of the company being audited, otherwise there will be no food.
It can be said: GMP originates from 13485 but requires details. Higher than 13485, there are many veto items that must be achieved.
2? CE is the European Union certification. The United States needs to register with FDA, depending on the product category, ISO 13485, international certification, is the ISO system certification for medical industry enterprises
3? Because Medical products are special products that are used to save lives, prevent and cure diseases. The basic requirement for their quality is safety and effectiveness. It is not enough to regulate medical device manufacturers only in accordance with the general requirements of the ISO9000 family of standards. To this end, ISO issued the ISO13485 standard, which puts forward special requirements for the quality management system of medical device manufacturers.
The focus of GMP is on the more comprehensive and specific objective requirements such as production equipment conditions, environmental factors, personnel, and institutional factors in the entire process from product planning and development to implementation.