ISO13485 is the most accepted standard for medical device manufacturers worldwide (e.g., USA, Japan, Canada, eu). This standard includes requirements specific to the industry and defines other terms such as medical devices, active medical devices, active transplant devices, and sterile medical devices
System function
1. Improve and improve the management level of the enterprise, avoid legal risks, and increase the visibility of the enterprise;
2. Improve and guarantee the quality level of products, so that enterprises can obtain greater economic benefits;
3, conducive to the elimination of trade barriers, access to the international market pass;
4. It is conducive to enhancing the competitiveness of products and increasing the market share of products;
5. Effectively reduce the risk of product quality accidents or adverse events through effective risk management.
6. Improve the sense of responsibility, enthusiasm and dedication of employees.
Authentication conditions
1. The applicant organization shall hold the business license of the legal person and documents proving its legal status;
2. It has obtained the production license or other qualification certificate (when required by national or departmental regulations);
3. The products covered by the quality management system applied for certification shall meet the relevant national standards, industry standards or registered product standards (enterprise standards), and the products shall be finalized and produced in batches;
4, apply to the organization shall establish plans to apply for certification standard management system, for the production of medical equipment, enterprises should also accord with the requirement of YY/T 0287 standard, the production of three types of medical equipment enterprises, quality management system running time not less than 6 months, production and other products of enterprises, the quality management system running time of not less than three months. At least one comprehensive internal audit and one management review have been conducted.
5. In the one year before the certification application, the products of the application organization have no major customer complaints or quality accidents.
Apply to industry
1. General medical devices;
2. Active implantable medical devices;
3. Active medical devices;
4. Implantable medical devices;
5. Sterilized medical devices.
Price factor
Factors affecting project price include:
1. Enterprise scale (including number of employees, product type and technology);
2. Current management level and status of the enterprise;
3. The effect required by the project (such as the degree of management improvement).
Service process
Quick process: contract signing -- > details understanding -- > establishment data -- > on-site audit -- > evidence collection.
Management project process: status diagnosis -- > basic training -- > process planning -- > process writing -- > process discussion and review -- > system trial operation -- > system landing -- > certification.