E-BEAM Services Inc. is an industry leader in resources for ISO 11137 and ISO 13485 Certifications. We meet the requirements as set forth by the US Food and Drug Administration (FDA), and our facilities are registered and audited by the FDA.
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E-BEAM SERVICES INC. LOCATION CERTIFICATIONS:
We are proud to provide our ISO certificates for each location.
Please select a link below to view the appropriate ISO certificate.
ISO 9001:2008 – Lebanon, OH, Cranbury, NJ, & Lafayette, IN
ISO 11137-1:2006 – Lebanon, OH, and Cranbury, NJ facilities
ISO 13485:2003 – Lebanon, OH, and Cranbury, NJ facilities
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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. ISO 11137 and ISO 13485 certificates are issued when compliance is achieved.
You can be assured products processed by E-BEAM Services will conform to the Regulatory Requirements established by law and statute.
Why Choose E-BEAM Services Inc.:
The thing that sets E-BEAM apart from other companies is our people. We’re innovators, thinkers, tinkerers. Our customers’ best outcome is what we aim for. We won’t settle for anything less.
Our core value is commitment–that’s commitment to the power of electrons in the form of well run, long-term, state of the art facilities, commitment to our employees, and commitment to our customers and the great products they make.