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Certifications

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 Certified
MDSAP Certified

Avalign Additive | Slice Manufacturing Studios
FDA registered 3013413393
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

German Specialty Instruments
FDA registered 8010372
ISO 13485 certified

Integrated Medical Solutions
FDA registered 1527105
ISO 13485 certified

Thortex
ISO 13485 certified

 


Featured Products

  • Flex Technology
  • IM Flex Reamers
  • Flex Shafts
  • PSO
  • Steripack

Recent News

Acquisition of Slice Manufacturing Studios

Feb 16, 2021

Avalign Technologies Names Jeff McCaulley CEO

Aug 13, 2019

SurgiBit

Jan 31, 2019

Platforms

Implants

Porous Coatings

Precision Machined Instruments

German Specialty Instruments

Delivery Systems

Cutting Instruments

Metal Injection Molding

Spine & SportsMed Implants



Divisions

Avalign Orthopedic
Avalign Surgical

Platforms

Implants
Porous Coatings
Precision Machined Instruments
German Specialty Instruments
Delivery Systems
Cutting Instruments
Metal Injection Molding

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Avalign Technologies, Inc.
10275 W. Higgins Rd Suite 920
Rosemont, IL 60018
info@avalign.com
O (847) 457-4300
F (847) 457-5305

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