Neobiotech’s quality management emphasizes the protection of public health and welfare in the interest of our global community and therefore, ensures good quality management systems.

By complying with international laws and regulations in the field of medical industry, we maintain high quality standards for our products and services.

ISO 13485

Neobiotech is fully compliant with ISO 13485, which is the international standard established by the International Organization for Standardization for quality management systems for medical devices in the production process.

CE MDD (CE1639)

The CE mark indicates that the Neobiotech conforms to the EU’s medical device guidelines. Thanks to the Declaration of Conformity and the CE approval, NeoBiotech exports its products in any part of the European Economic Area.

CE (2195-MED-2111902)

Neobiotech obtained CE certification that meet the highest global quality, safety and sustainability standards by conforming to the Full Quality Assurance under EU’s medical device guidelines from SZUTEST.

US FDA (K190849)

The Neobiotech obtained CLASS-II certificate from the FDA, which evaluates the safety and efficacy of all kinds of medicine, food, and medical devices that are sold in the U.S

Certification in China

The Neobiotech obtained the registration certificate for medical device to sell medical devices from the NMPA in China

Certification in Costa Rica

The Neobiotech obtained the registration certificate for medical device to sell medical devices in Costa Rica

Certification in Japan

The Neobiotech obtained the registration certificate for medical device to sell medical devices from the PMDA in Japan

Certification in Russia

Neobiotech obtained certification by observing the Gosstandart of Russia (GOST-R) for medical device to sell medical devices in Russia.

Certification in Taiwan

The Neobiotech obtained the registration certificate for medical device to sell medical devices from the TFDA in Taiwan

Certification in Thailand

The Neobiotech obtained the registration certificate for medical device to sell medical devices from the TFDA in Thailand

Company-Affiliated Research Institute

Neobiotech Implant R&D Center was recognized as a company-affiliated research institute by the Korea Industrial Technology Association, which is an affiliated agency under the Ministry of Science, ICT and Future Planning.