The full name of the ISO13485:2003 standard is "Medical device-Quality management system-requirements for regulatory". The standard is formulated by the SCA/TC221 Medical Device Quality Management and General Requirements Standardization Technical Committee and is an independent standard based on ISO9001:2000. The standard specifies the quality management system requirements for relevant organizations, but it is not a guide for the implementation of the ISO9001 standard in the medical device industry.

Scope of application of ISO13485 certification

This standard applies to related industries such as the design and development, production, installation and service of medical devices or the design, development and provision of related services.

A medical device as defined in the standard means an instrument, device, appliance, machine, appliance, implant, in vitro Reagents or calibrators, software, materials or other similar or related items. These purposes are:

- diagnosis, prevention, monitoring, treatment or alleviation of diseases;

- diagnosis, monitoring, treatment, mitigation or compensation of injury;

- the study, substitution or adjustment of anatomical or physiological processes;

- support or sustain life;

- pregnancy control;

- disinfection of medical devices;

- To provide medical information by means of in vitro examination of samples taken from the human body.

Its main design effect on the human body surface or in vivo is not obtained by pharmacological, immunological or metabolic means, but these means may be involved and play a certain auxiliary role.

What are the benefits of passing ISO13485 certification?

1. ISO13485 has become a mandatory certification, which is increasingly valued by government agencies in Europe, America and China, which is conducive to eliminating technical barriers in international trade and is a pass to enter the international market;

2. Increase the reputation of the company;

3. It can improve and ensure the quality level of products, so that enterprises can obtain greater economic benefits;

4. Enhance the competitiveness of products.

5. It can improve and standardize the internal work flow and system of the enterprise.