Quality

SteriTek is an ISO 13485 certified, FDA registered, DEA registered, CBER Tissue Registered, MedAccred Certificates well as State of California Medical Device and Drug Manufacturing licensed facility.

To request a Quality Manual, please send an email to our Quality Department at quality@steri-tek.com.

SteriTek is FDA Registered: (Owner Operator Number: 10051493)

Certifications

ISO Certification
International Irradiation Association
DEA Registration
FDA Registration
MedAccred Sterilization Accreditation
State of California Device Manufacturing License
State of California Drug Manufacturing License
Japanese Ministry of Health Registration
Women/Minority Business Enterprise (WMBE) Certified

With its advantages over almost all other current sterilization techniques, X-ray sterilization is the up and coming sterilization technique and warrants your consideration both for new products and for transition of current products. Already included in international standards and FDA guidelines, the usage of X-ray sterilization is already approved by regulatory bodies. The current, biggest challenge, as with any new technology, is finding facilities that offer this service. This should not be a problem in the years to come.