Achieving Qualification

Scaling additive production requires qualification. In regulated industries, such as orthopedics and aerospace, rigor is even more important. Our additive experts have experience qualifying hardware in highly regulated markets and can help you reduce the learning curve so you can get your product to market faster. In the end, you will qualify the machine, the material, and the process. We follow industry-wide processes to establish robust and repeatable production outcomes.

Installation Qualification (IQ
The purpose of the IQ protocol is to provide documented evidence that the machine is installed according to documented and pre-approved specifications.

Operational Qualification (OQ)
The purpose of OQ is to demonstrate that a system operates according to written pre-approved specifications throughout a specified operating range.

Performance Qualification (PQ)
The purpose of PQ is to demonstrate that the additive process, under anticipated manufacturing conditions, consistently produces product(s) that meet all engineering requirements.