Quality

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.
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 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.
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
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 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 Costa Rica
The Neobiotech obtained the registration certificate for medical device to sell medical devices in Costa Rica
Certification in Indonesia
The Neobiotech obtained the registration certificate for medical device to sell medical devices in Indonesia
Certification in Indonesia
The Neobiotech obtained the registration certificate for medical device to sell medical devices in Indonesia
Certification in Japan
The Neobiotech obtained the registration certificate for medical device to sell medical devices from the PMDA in Japan
Certification in Japan
The Neobiotech obtained the registration certificate for medical device to sell medical devices from the PMDA in Japan
Certification in Malaysia
The Neobiotech obtained the registration certificate for medical device to sell medical devices in Malaysia
Certification in Malaysia
The Neobiotech obtained the registration certificate for medical device to sell medical devices in Malaysia
Certification in Mexico
The Neobiotech obtained the registration certificate for medical device to sell medical devices in Mexico
Certification in Mexico
The Neobiotech obtained the registration certificate for medical device to sell medical devices in Mexico
Certification in NewZealand
The Neobiotech obtained the registration certificate for medical device to sell medical devices in NewZealand
Certification in NewZealand
The Neobiotech obtained the registration certificate for medical device to sell medical devices in NewZealand
Certification in Peru
The Neobiotech obtained the registration certificate for medical device to sell medical devices in Peru
Certification in Peru
The Neobiotech obtained the registration certificate for medical device to sell medical devices in Peru
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 Russia
Neobiotech obtained certification by observing the Gosstandart of Russia (GOST-R) for medical device to sell medical devices in Russia.
Certification in Serbia
The Neobiotech obtained the registration certificate for medical device to sell medical devices in Serbia
Certification in Serbia
The Neobiotech obtained the registration certificate for medical device to sell medical devices in Serbia
Certification in Taiwan
The Neobiotech obtained the registration certificate for medical device to sell medical devices from the TFDA in Taiwan
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
Certification in Thailand
The Neobiotech obtained the registration certificate for medical device to sell medical devices from the TFDA in Thailand
Certification in Ukraine
The Neobiotech obtained the registration certificate for medical device to sell medical devices in Ukraine
Certification in Ukraine
The Neobiotech obtained the registration certificate for medical device to sell medical devices in Ukraine
Certification in Vietnam
The Neobiotech obtained the registration certificate for medical device to sell medical devices in Vietnam
Certification in Vietnam
The Neobiotech obtained the registration certificate for medical device to sell medical devices in Vietnam
Certification in Singapore
The Neobiotech obtained the registration certificate for medical device to sell medical devices in Singapore
Certification in Singapore
The Neobiotech obtained the registration certificate for medical device to sell medical devices in Singapore
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.
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.