Quality Assurance

MedOne Surgical firmly believes that the most important feature of a medical device is quality. The product must work as intended, every time. At MedOne, we utilize a rigorous quality system of design, inspection and testing to ensure our products are of the highest possible quality.

MedOne undergoes annual quality system audits to ensure compliance with all relevant quality standards for our products. MedOne is certified for compliance with ISO 13485, and meets all requirements for the CE mark.

MedOne is registered with the US FDA and operates in compliance with requirements of the US FDA Quality Management System (21 CFR Part 820) relevant to our products.

If you have a question, comment or complaint about any of our products, please contact us.