ViOL, a company specializing in energy-based medical devices (EBD), announced that its Quality Management System (QMS) has successfully completed an audit in accordance with the EU Medical Device Regulation (MDR, 2017/745) and received EU QMS certification from the European certification body TUV SUD (0123).
This MDR QMS certification is the result of official recognition that ViOL’s quality management system meets the strengthened regulatory requirements of the EU MDR:
- Clinical and safety verification system
- Post-market performance surveillance (PMS/PMCF)
- Technical documentation management (Annex II/III)
- Risk and quality management process.
With this, ViOL has established a foundation to actively pursue the process of obtaining technical documentation (TD) for each product and MDR CE certification in the future. In particular, Viol has established itself as the first company in Korea to obtain MDR certification in the field of microneedle high-frequency equipment, once again securing international credibility for its technological prowess, safety, and quality management system.
The European Union has been fully implementing the MDR since 2021, which significantly strengthens the requirements for:
- Clinical data quality
- Performance and safety verification procedures
- Post-market surveillance compared to the existing MDD.
Obtaining this MDR QMS certification, which passed a rigorous process, is considered a key milestone in strengthening Viol’s global competitiveness.
Based on this certification, Viol plans to accelerate its expansion strategy into the Middle East and Asian markets, including major European countries, which recognize CE certification.
“EU MDR QMS certification is a significant achievement that proves that Viol’s quality management system meets the world’s highest standards,” said Eun-Cheon Lee, CEO of Viol. “We will sequentially pursue MDR certification for each product to strengthen our presence in the European market and promote the value of K-medical aesthetic equipment to the world.”
