Otoharmonics ISO 13485 Quality Management

//Otoharmonics ISO 13485 Quality Management

Otoharmonics implemented Novunex as electronic Quality Management System for their ISO 13485 compliance

Otoharmonics  is an international acting company of the medical device industry. Located in Portland, OR they have created a device that is designed to improve the life of tinnitus patients significantly with an easy-to-use audio therapy. As a medical company, Otoharmonics is compliant to the ISO 13485 standard. To improve their efficiency, Otoharmonics has implemented Novunex as their eQMS system.

Q: Why did you chose Novunex eQMS?

A: We have changed to Novunex to satisfy our customers’ requirements of having an online order system, and since then we have seen anything but improvements, on the way we interact with our customers, on our quality metrics, on our efficiency, etc.

Q: What specific feature did you like most about Novunex eQMS?

A: Definitely the intuitive design. Our customer support team has seen plenty of benefits of working with the system, their daily work has become easier and the system has helped us to a have a better tracking of our activities.

Q:What are other benefits of Novunex eQMS?

A: Implementing the system was very easy. The Novunex team is always available and helped us solving any issues and listened to all our requests for updates and new implementations for our system. Which also made us using Novunex for other operations in the company.

Q: Would you recommend Novunex eQMS? If so, why?

A: The system has helped us going through a ISO 13485 surveillance audit. Not only that we passed the audit, the auditor was very impressed how the system works.

By | 2018-03-20T08:53:33+00:00 February 21st, 2018|Categories: Success Stories|Tags: , , |Comments Off on Otoharmonics ISO 13485 Quality Management

About the Author:

Theresa Gangloff
Theresa works as a Medical Regulatory Engineer. She has years of experience in leading SCM and QMS projects in highly regulated environments. She is facilitating design sessions with customers in the medical device manufacturing and automotive industry to define solutions and delivering outstanding systems.