System Certification

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ISO 13485


ISO 13485, first enforced in the 1990s, is a quality management system standard specialized in the medical device industry and contains customer requirements and other major regions around the world such as Europe (EU) and Canada. In addition to the ISO 9001 standard, it includes all requirements for industry-specific medical devices. Specifically, EN ISO 13485:2016 integrates the three EU medical device directives (medical devices, in vitro diagnostic devices and active implantable devices).


Necessity of ISO 13485

ISO 13485, which is a certification for medical devices, is in most cases mandatory and provides advantages for medical device companies exporting products to foreign markets. In the EU, full compliance with EU directives (e.g. Active Implantable Medical Devices Directive, Medical Devices Directive, In Vitro Diagnostic Devices Directive) means that the free trade of medical devices is permitted. The most important part of complying with the requirements of the EU Directive is the establishment of a quality system and independent evaluation. The current European medical device quality system standard is EN ISO 13485:2016. When manufacturers are active in the global marketplace, focusing on global or international standards (e.g. ISO) offers several advantages, as well as being mandated by law in some countries. For example, Canada requires that manufacturers of medical devices selling in their market must have a quality system certified according to ISO 13485:2016.

What is the EN ISO 13485: 2016?

In March 2016, the European Committee for Standardization (CEN) published amendments to the European standard, EN ISO 13485:2016. This amendment merely amended the preamble so that the European standard can be used bindingly. The purpose of this amendment is to replace the previous EN 46003. For example, I added references to various parts of Module E. It interfaces EN ISO 13485:2016 with Annex VI (final audit) of MDD. As such, manufacturers can now be audited to the 13485 standards under Annex VI. However, there are no changes that directly affect the manufacturer.

Eligible for Certification

  1. Companies that currently manufacture their own brand medical devices, but ultimately want to market these devices under their own brands on the EU market.
  2. Consulting companies and agencies that design, produce and assemble medical parts manufacturers and medical devices and in vitro diagnostic medical devices
  3. Manufacturers of in vitro diagnostic medical devices that want to differentiate themselves and prepare for the obligations of the next IVD regulation to enter the European Union