ISO Certified Regulatory
International Organization of Standardization (ISO) establishes the quality management system guidelines for the manufacturing of medical equipment. UVLrx Therapeutics Inc. has received ISO 13485 certification for its state-of-the-art facility in Florida, USA. Our certification and exceptional team of engineers and assemblers ensure that the highest quality of medical equipment is designed, assembled, and maintained.
Non-Significant Risk Determination
The UVLrx Treatment System was granted a non-significant risk classification in association with clinical trials conducted in the U.S.
UVLrx Clinical Studies
All studies conducted by UVLrx Therapeutics Inc. are in accordance with Good Clinical Practice (GCP) as required by the following:
United States (US) Code of Federal Regulations (CFR) applicable to clinical studies (45 CFR Part 46, 21 CFR Part 11, 21 CFR Part 50, 21 CFR Part 56); ICH E6; 62 Federal Register 25691 (May 9, 1997); Good Clinical Practices