AAAM 44.9:OS — Orthopedic and Spinal Implants

Orthopedic implant parts are among the most notoriously difficult parts to inspect using traditional methods.  Metr0logy firms have reported a high level of resistance from implant manufacturers, who are afraid that advanced tools might introduce or exacerbate regulatory problems.  Fear, therefore, is largely responsible for the perception that medical device manufacturers are "stuck in the past".  To neutralize these concerns, metrology firms need to have a highly specialized skill set in order to meet the technical challenges while also complying with exacting PMA, 510(k), or CE Mark requirements.

In addition to the basic specifications for general application of advanced metrology, the American Association of Advanced Metrology offers a specific endorsement for testing laboratories, agencies, institutions, manufacturers and other practitioners to apply advanced metrological technologies to the inspection of orthopedic and spinal implants.

AAAM 44.9 certification with Orthopedic and Spinal Implants endorsement (AAAM 44.9:OS) is conferred on candidate laboratories that can demonstrate, via Gauge R&R and the tiered  application process, the ability to perform measurements and sophisticated data analysis of at least the minimum accuracy required by the quality and safety standards prevalent in the medical device industry.