Quality Systems for Orthopedic Manufacturing

In the orthopedic and spine manufacturing market, ISO 13485 has become a standard that is expected from all contract suppliers. We are proud to have been one of the first contract manufacturing companies to obtain this registration.

At DiSanto, we place the highest priority on quality system development, implementation, and follow-through.

Key highlights of our quality systems are:

  • • All machine operators trained as inspectors.
  • • Inspection plans developed for all parts machined.
  • • Gagetrak used for all gage tracking.
  • • First piece and every 5th piece critical data collected.
  • • Key dimensions checked via CMM (4 total CMMs).
  • • Customer complaint tracking/improvement program.
  • • Risk management assessment.
  • • Critical process validation programs.
Certificate of Registration: ISO 13485:2003
Certificate of Registration: ISO 900 1:2008