Andyforce Obtains Medical Device Quality Management System Certification... Expanding into Overseas Markets

[Asia Economy Reporter Park Hyungsoo] AndyForce has obtained international standard certification related to the establishment of a factory for the production of novel coronavirus disease (COVID-19) diagnostic kits.

On the 12th, AndyForce announced that it has acquired the international standard medical device quality management system (ISO 13485) certification for the KGMP factory producing RT-PCR diagnostic kits and immunodiagnostic kits intended for COVID-19 diagnosis.

ISO 13485 is an international standard established by the International Organization for Standardization (ISO) that verifies whether a specialized management system and quality control system for the medical device industry have been secured. It is one of the most trusted certification systems worldwide.

Among the standards certified by ISO, the certification applied to the medical field, which deals with life, has more stringent certification procedures than other industries. ISO 13485 can only be obtained by meeting the conditions required by countries with high-quality management standards such as Europe and Canada. Companies that receive this certification are evaluated as having the appropriate qualifications to export medical devices to major countries worldwide.

Kim Jangho, CEO of AndyForce, stated, "AndyForce, having obtained this certification, has been objectively recognized for its system and operational capability to produce and manage medical devices," and introduced, "ISO 13485 is a standard that companies providing medical device-related services in overseas markets must obtain."

He added, "After obtaining ISO 13485 certification, we plan to pursue European CE certification and domestic medical device item approval," and "AndyForce will establish a foundation to enter overseas markets focusing on medical devices."

This content was produced with the assistance of AI translation services.