Manufacturing and Distribution

The majority of our sealed source products are categorized as Class 1 medical devices, and are developed, manufactured, packaged and distributed in compliance with US FDA 21 CFR 820 regulations. To ensure we delivery quality products in compliance with applicable regulations, we’ve developed and certified our quality management system to ISO 13485:2016 and ISO 9001:2015.

We are compliant to European Union (EU) and United Kingdom Medicines and Healthcare Products Regulatory Agency (MHRA) medical device regulations with registered agents in the European Union and the United Kingdom which authorizes the import of our medical devices into these regions.

Distribution of radioactive materials are packaged and shipped in compliance with applicable US Department of Transportation (DOT) and US Nuclear Regulatory Commission (NRC) requirements.

RadQual is an International Isotopes, Inc. company.