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Zassi Medical Evolutions, Inc.

Zassi Medical Evolutions, Inc. logo

Like all medical device manufacturers, Zassi Medical Evolutions, Inc. must adhere to strict regulatory standards for manufacturing and quality, including FDA’s Good Manufacturing Practices and the 21 CFR 11 standard for their electronic records . When a medical device company does not comply, government levied fines can threaten its very survival.

Zassi was using an internal server-based application to handle their Quality System Record management. This solution was outdated, tied up staff with unnecessary administrative and IT tasks, and was too expensive to upgrade.

Zassi wanted to manage their QSR and maintain compliance in the most flexible but painless way possible, and focus on providing innovative medical device technology to help patients. The company needed to manage detailed product data and minimize document control burdens.


1.866.937.1438 | Arena PLM gave Zassi Medical Evolutions, Inc.:

  • Trustworthy record keeping
  • Flexible yet robust change management.
  • A ready-to-implement Validation Kit for compliance with government standards, featuring templates for ease of use.
  • Instant deployment.
  • Low initial investment with monthly subscription model.
  • Web-native architecture to cut down on internal systems administration

The company adopted Arena PLM and used Arena’s Validation Kit to execute its compliance efforts, running the entire validation within one week. Zassi’s Vice President of Manufacturing estimates that the kit saved the company thousands of dollars and at least one month of work in validation effort.

www.zassimedical.com