MedGyn is licensed and certified by the leading regulatory authorities, including the U.S. FDA, CE 0482, and ISO 13485 for manufacture and distribution in the United States and internationally.
Our products are manufactured to comply with stated, as well as implied quality system standards dictated by the:
- United States Code of Federal Regulations (Title 21, Part 820)
- European Medical Device Regulations (MDD 93/42/EEC)
- International Standards Organization (ISO 13485)