Medical aesthetics company RF Bio has earned an international occupational health and safety management certification as it moves to strengthen safety management at production sites and its manufacturing and quality competitiveness.
RF Bio said Sept. 11 that it had received ISO 45001 certification from IGC Certification Institute.
ISO 45001 is an international standard for occupational health and safety management systems established by the International Organization for Standardization (ISO). It requires companies to identify and manage potential workplace safety and health risks in advance and establish systems for accident prevention, emergency response and continuous improvement.
Through the certification, RF Bio was assessed as having a management system that meets international standards for managing occupational health and safety risks, employee participation, accident prevention and emergency response.
Medical aesthetics products go through multiple processes, from research and development to raw material production, manufacturing, filling and packaging, and quality control. The company said that stable product production requires not only product quality itself but also safety at production sites and process management.
RF Bio develops and manufactures hyaluronic acid (HA) fillers and polynucleotide (PN) products. Its flagship products include the Youthfill HA Filler and Youthfill PN.
In April, the company completed an exploratory clinical trial of Youthfill PN+, a tissue-repair biomaterial combining PN and HA, and said it would pursue follow-up confirmatory clinical trials and the regulatory approval process. The company is developing the product with the goal of obtaining approval and launching it next year.
RF Bio has an in-house production system covering everything from raw materials to finished-product manufacturing and quality control. As it expands its overseas business, the company plans to meet global standards covering not only product performance but also overall corporate operations, including quality, environmental management and safety.
An RF Bio official said, “This ISO 45001 certification is not simply an opportunity to introduce a safety management system, but a step toward establishing the foundation for manufacturing competitiveness that supports product quality and stable production.”