Medical devices - Quality management systems - Requirements for regulatory purposes (hereinafter referred to as ISO 13485) was prepared by ISO/TC 210 Technical Committee on Quality Management of Medical Devices. ISO 13485:2016 is the first edition of ISO 13485, which was officially published by ISO in July 2003.

The current 2016 edition is an updated version of the standard formerly known as the Supplementary Requirements for Quality Management Systems for the Manufacture of Medical Devices (EN 46001/2) issued by the European Committee for Standardisation and the European Committee for Electrotechnical Standardisation (CEN).

ISO 13485: 2016 Medical Device Quality Management System is applicable to the medical device industry and to those involved in the pharmaceutical supply chain. The standard is based on ISO 9001, with particular emphasis on meeting the requirements of medical device laws and regulations, relevant medical industry-specific activities, and special regulations for where products are sold.It covers safety requirements, risk analysis and assessment, clinical investigation and evaluation, information feedback mechanisms, post-market surveillance, customer complaint investigations and recalls, alert systems, etc., as well as other technical standards and advisory circulars. In addition, there are additional requirements for design control, environmental control, special process control, traceability, record keeping and regulatory measures, making it the most comprehensive quality assurance standard for the design, manufacture and service of medical devices available. The quality management system requirements specified in this standard may be used when organizations need to provide medical device products that meet customer and applicable regulatory requirements.

In view of the inherent risks associated with the use of medical devices for medical purposes, advanced countries have put in place quality systems and regulations to ensure the effectiveness and safety of medical devices.

• Domestic
  • The Ministry of Health and Welfare, Executive Yuan, implements the Good Manufacturing Practice (GMP) for medical devices, which is based on the relevant provisions of the Pharmaceutical Affairs Law, the Chinese National Standard CNS 12681 (ISO 9001) and the International Standard for Quality Assurance of Medical Devices (ISO 13485). Domestic and imported medical device manufacturers are the scope of assessment and accreditation.

• Americas
  • USA: Manufacturers must be approved by the US Food and Drug Administration (FDA) to establish a quality assurance system before they can be marketed, and the preamble to the code mentions that it is harmonized with the ISO 13485 standard.
  • Canada: Manufacturers must have their quality management systems certified to ISO 13485 before they can sell their products in Canada.

• European region
  • In most cases, manufacturers are required to comply with ISO 13485 or EN46000 standards.

• Asia Pacific
  • The import certificate application process of each country's regulatory authority includes explicit or non-explicit requirements for manufacturers to show proof of compliance with ISO 13485 standards

We provide ISO QMS/ISO EMS/ISO 17025 training. In addition to a range of testing and calibration services, ETC has been engaged in training operations for over 30 years and has accumulated a wealth of training capabilities and experience. In addition, we have a range of EMC, safety and chemical testing and calibration laboratories, as well as international standards such as ISO, EN, BS, ANSI, ASTM, JIS and AS for medical devices and components, providing you with a complete, professional and integrated service.

Systematic model

• System planning stage - integration of international regulations, medical industry standards, customer requirements and the establishment of corporate organizational specifications and authority and responsibility structures.
• System construction stage - planning and construction of ISO 13485 standard procedures, operational processes and risk assessment management system (ISO 14971).
• System development phase - education and training, ISO 13485 standard management and technical standards and the establishment and promotion of records.
• System implementation phase - internal audit and correction, management review and ISO 13485 standard system operation, correction and technical capability integration.
• System validation phase - external audit validation service; including formal system validation registration and continuity assessment.