NANOBRICK acquierd International Standard Certification
for Bio-Extraction Reagents
- Acquired ISO13485 certification for international standard medical device quality management system following ISO9001 and ISO14001
- Reinforced the bio business through international certification for the manufacturing environment and quality system for gene extraction reagents
NANOBRICK (KOSDAQ:286750), a company specializing in advanced nano-materials, has announced the achievement of an international standard certification ISO13485 for the quality management system of its in vitro diagnostic gene extraction reagent products on the 26th May.
The international quality management standard ‘ISO13485’ in the medical device field is a certification that proves that the process of producing and providing medical devices and related services meets international standards, and is essential for exporting medical devices to major countries around the world.
Through the acquisition of this certification, NANOBRICK has raised the reliability of its biomolecular diagnostic extraction reagent products, and has been recognized for its international level of production environment and product quality management system.
NANOBRICK is expanding its M-Bead business, a key extraction reagent for molecular diagnosis, based on the mass production system of high-quality magnetic beads built through the high-tech security material business.
M-Bead, is expanding domestic and overseas applications based on uniform quality and high cost-effectiveness compared to global leading companies, and is expanding its supply into a molecular diagnostic reagent market for various diseases such as tuberculosis, hepatitis B, and sexually transmitted diseases in addition to virus diagnosis such as Corona 19.
In particular, through the establishment of a Bio Lab facility in Gwanggyo in January this year, it is enhancing customer satisfaction by reinforcing bio characteristics and quality-evaluation functions.
An official from NANOBRICK said, “The genetic nucleic acid extraction step is the first step and core function in the disease diagnosis process, and quality optimization of magnetic nanoparticles, buffer solutions, and measurement systems is required.” and said “By acquiring the ISO 13485 certification of the medical device quality management system this time, we are equipped with thorough quality control capabilities for the manufacturing and management of a series of bio-extracting reagents, following the acquisition of ISO9001 certification, an international standard for quality management system for the development and manufacturing of existing nanomaterials , and ISO 14001 certification, an international environmental management system.”
On the other hand, NANOBRICK is expanding its business operations to △ anti-counterfeiting and advanced security material business △ bio-molecular diagnostic extraction material business △ functional display material business based on the Active Nano Platform that can produce various functional nano materials. (End)