Our processes are validated to meet or exceed FDA requirements for equivalence to original equipment manufacturer (OEM) specifications for new devices.
Validation testing for 510(k) clearances is very stringent and verifies that devices are clean, functional and sterile.
- Total organic residues are as low as new devices.
- Biological residues are equivalent to reusable devices.
- Every single device is functionally tested where applicable.
- Restoration does not introduce new failure modes.
- Sterilmed uses the nation's largest third- party sterilizer.
- This sterilizer is used by many leading OEMs.