APS Materials, Inc.

Quality: ISO 9001

The standards maintained by APS Materials, Inc. are as diverse as our applications. ISO 9001 is a world-class international quality standard, AS9000 and NADCAP are both aerospace standards, and we uphold FDA standards for Biomedical services. These standards not only assure our customers of our quality services and procedures, it provides APS Materials with the highest standards to measure our performance as a quality supplier of TS services and other manufacturing capabilities.

APS Materials and the FDA

The relationship between APS Materials, Inc. and the FDA has been based on mutual scientific respect, providing our company with many advantages over our competitors.

In 1996, reports by the FDA’s orthopaedic advisory council claimed that "freed" particulate from plasma sprayed titanium coatings had been observed to work its way into the mechanical joint area, causing premature failure. That report triggered a response from the FDA mandating a three-year post surgical surveillance on every new orthopaedic product that made use of plasma sprayed coatings. Our response to this action was two-pronged. (1) We researched and gathered test data from our customers in order to review this action, and (2) we engineered a groundbreaking low-debris coating system with comparative testing against other coatings formed by other technologies and submitted a new Master File based upon these data. As of 1999, the submission of our new orthopedic and dental Master Files to the FDA released orthopaedic customers from performing post-market surveillance on the high quality plasma sprayed metallic coatings exclusively from APS Materials, Inc.