Since 1996 APS Materials has been certified to the quality system standard of ISO 9001:2015. This standard is widely used on a global basis and its requirements include process and customer satisfaction focus with emphasis on management involvement and continual improvement.
APS Materials is certified for the design, development and manufacture of thermal spray coatings and cathodic protection devices for products in the aerospace, semiconductor and material processing industries. Cathodic protection products are used to measure and mitigate the corrosion of pipelines, AST bottoms, ships, locks and most any other underground or underwater metal structure.
With ISO 9001:2015 adherence APS Materials assures our clients that our services are managed to provide the expertise and results that the quality system demands.
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.