ISO13485, an international standard for medical device quality management system. So enterprises can design and develop standards for medical devices, production, installation and service, as well as the design, development and provision of related services, but this standard may also be used for internal and external (including certification bodies) to assess the organization to meet customer and regulatory requirements Ability. Obtain ISO13485 certification gives you the upper hand in European and global markets. This certification is you sell products on the market in other countries a prerequisite.

ISO13485 Requirements

     -  ISO13485 builds on the ISO9001 process mode.
     -  ISO13485 global basis to meet the various regulatory model established quality system requirements.
     -  Due to changes in regulatory requirements into focus mode, ISO13485 writers will emphasize the partial deletion of customer satisfaction of ISO9001.
     -  ISO13485 has not been adopted by FDA, FDA will continue to adhere to its independent Quality System Regulation (QSR). However, FDA staff involved in the preparation ISO13485 and ISO13485 standards confident they can be parallel. Thus, a company in line with ISO13485 requirements is also very easy to reach FDAQSR requirements.
     -  TR14969 is the use and implementation of ISO13485 guidelines.

     -  ISO13485 propulsion mode but not in accordance with the business as a holding in accordance with the procedure established the validity of the Utility mode.
     -  Different with ISO9001, ISO13485 does not allow manufacturers reasonable reductions files. To ensure that the company complies with regulatory requirements, ISO13485 appears to be more descriptive and process documentation still needs to establish certain requirements.
     -  ISO13485 risk management is a very critical factor.
     -  Between ISO13485 and ISO9004 (Quality Management System based on the standard) no significant link.
     -  ISO13485 and other "non-quality" management systems such as ISO14001 and ISO45001 compatible.