E-BEAM Services’ Quality System meets the requirements set out by the US Food and Drug Administration (FDA), and our facilities are registered and audited by the FDA. We also work with customers that market their products in Europe (as well as other parts of the world), so we assure compliance with the EU Guidelines to Good Manufacturing Practice for Medicinal Products and the European Council Directive Concerning Medical Devices.

ISO Medical Device Certification

There are two sets of FDA standards, one for Medical Devices (21 CFR Part 820) and one for Drugs, (21 CFR Parts 210 and 211). The FDA also recognizes two Industry Standards and expects compliance with them. The first is ISO 13485 certification, covering Quality Management Systems for Medical Devices, and the other is ISO 11137, which deals with Sterilization of Health Care Products using radiation.

In order to ensure ISO medical device compliance with these standards, E-BEAM Services sterilizes in accordance with International Standards for the operation of our equipment, dosimetry systems, and product qualification. E-BEAM is audited by a third party registrar — to provide an independent assessment of our Quality Management System.

You can be assured products processed by E-BEAM Services will conform to the Regulatory Requirements established by law and statute.

ISO 13485:2016