Tegra Engineering, Inc.

Tegra Engineering has been designing and building custom automation equipment for the medical device assembly industry since our company was founded. We have built many automated medical device assembly systems over the years in accordance with the GAMP 4 Guide, and we understand the FDA validation requirements to which our medical device assembly automation equipment and pharmaceutical customers must comply.

Medical Device Assembly Automation Design for Validation:

□   Tegra Engineering designs automation equipment for installation in clean room environments.

□   We custom manufacture all contact tooling utilizing only non-contaminating materials.

□   We design calibration tools and procedures for each online measurement test.

□   Computer programs are written to insure critical sensors function each cycle of the machine.

□   Computer program structures are written in a format easy to validate.

□   Reject stations are designed with sensors to verify out of specification product is properly removed. Rejected product

     is often marked or purposely damaged to prevent accidental usage.