ISO13485 certification is the most accepted standard for medical device manufacturers worldwide (e.g., USA, Japan, Canada, European Union).
This standard includes requirements specific to this industry and defines other terms such as medical devices, active medical devices, active transplant devices, and sterile medical devices

 

System function

Improve and improve the management level of the enterprise, avoid legal risks, increase the visibility of the enterprise

Improve and ensure the quality level of products, so that enterprises to obtain greater economic benefits

Help to eliminate trade barriers, access to the international market pass

Help to enhance the competitiveness of the product, improve the market share of the product

Through effective risk management, the risk of quality accidents or adverse events can be effectively reduced

Enhance staff's sense of responsibility, initiative and dedication

 

Authentication conditions

The applicant organization should have a legal person business license and documents proving its legal status

Have obtained the production license or other qualification certificates (when required by national or departmental regulations)

The products covered by the quality management system applying for certification should conform to the relevant national standards, industry standards or registered product standards (enterprise standards), and the products should be finalized and produced in batches

To apply for the organization shall establish plans to apply for certification standard management system, for the production of medical equipment, enterprise should also meet the requirements of the YY/T 0287 standard 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 full internal audit and one management review have been conducted.

Within one year before the application for certification, the products of the applicant organization have no major customer complaints and quality accidents.

 

Applied for industries

General medical devices;

Active implantable medical devices;

Active medical instruments;

Implantable medical devices;

Sterilized medical devices.

 

Service process

Quick process: sign the contract -- understand the details -- establish the data -- on-site audit -- evidence collection

Management project process: status diagnosis -- basic training -- process planning -- process writing -- process discussion and review -- system trial run -- system implementation -- certification

▇ Advantages of standard measurement certification ▇

Standard testing and certification work closely with the US TCB organization to help companies complete the one-stop service from organizing data to obtaining certification. Short issuance time, preferential price, and time-saving is the best choice for enterprise certification

Standard Testing and Certification is a professional, comprehensive and experienced certification service organization. The senior professional team has been providing products with certification experience in countries all over the world for more than ten years.

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