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Franklin, NJ
Milford, MA
Union, SC
Salem, SC
R&D testing and bio-compatibility evaluations.
Per ISO 11135 and CFR 820 QS requirements we can validate your product in our 3M Steri-VacTM sterilizers in preparation for routine sterilization at our facility or in preparation for acquisition of your own Steri-VacTM systems.
2-3 Day turnaround service using 3MTM Rapid Readout BI (RRBITM) technology with three(3) Steri-VacTM chambers available.
Your Master Challenge Pack / IPCD or EPCD compared with our patented PCDs to establish a better, more consistent process challenge device.
We can reproduce any Hospital / Healthcare EO cycle to permit compliance testing per the 2 May 2011 FDA Draft Guidance document. This typically will be carried out in cooperation with other independent test laboratories to confirm compliance to a Medical Devices Manufacturer's IFU for any reusable device.
