downtime or interruption in day-to-day operations when forced to transition company to remote work
unannounced remote audit by Health Canada performed and PASSED.
The current solution in place became an obstacle to company growth, pushes into additional markets, and a changing regulatory environment.
Zyris partnered with Greenlight Guru to upgrade their quality system to a platform designed for medical device companies coupled with an amazing customer experience.
While modifying their quality system for full EU MDR implementation, Zyris has navigated through several Notified Body audits successfully and a week-long surprise audit from Health Canada, which was performed — and passed—remotely.
Founded in 2001, Zyris, Inc. began with a clear mission of elevating dental experiences for patients, providers, and practices with patented designs in dental isolation technology.
HQ: Santa Barbara, CA, USA
Device Classification: Class I
Selling into: USA, Canada, Europe, Australia, Japan
Greenlight Guru Champion:
Morris Sherwood, Person Responsible for Regulatory Compliance
According to Zyris, when navigating this new era of regulatory updates, changes, and hurdles it all comes down to your quality management system, or more specifically, finding your QMS partner.
With the changes brought forth by Regulation (EU) 2017/745, Sherwood and his team realized that they needed to change some of their processes quickly and efficiently.
Challenges with their eQMS solution became an obstacle to their future. With the inevitable stresses that come with company growth, pushes into additional markets, and a changing regulatory environment - The solution in place wasn’t helping.
Sherwood recognized they needed not only a software solution but a partner in regulatory requirements instead of a one-size-fits-all tool.