Throughout the manufacturing process, each phase is continually monitored for quality compliance. We strive to maintain a quality system that not only satisfies all regulatory requirements, but also provides us with the foundation to produce the highest quality products possible.

Avalign's quality engineers and product/manufacturing engineers are assigned to specific customers. This system provides a superior knowledge and relationship base to better serve our customers.

Working with our customers, we develop quality plans to ensure that we correlate with our customers inspection methods and that we focus on the appropriate critical items. This process enables us to verify that the parts meet customer prints and specifications - both as final components and as final assemblies.

Avalign Technologies and its manufacturing facilities have achieved the required quality certifications as shown below. 

Avalign Technologies
FDA registered 3008864603
ISO 13485 certified

Instruments and Implants
FDA registered 3006128100
ISO 13485 certified

Cutting Instruments
FDA registered 1835251
ISO 13485 certified

Delivery Systems
FDA registered 1835444
ISO 13485 certified
CE registered (SteriPack only)

German Specialty Instruments
FDA registered 8010372
ISO 13485 certified

Thortex
ISO 13485 certified