zero

downtime or interruption in day-to-day operations when forced to transition company to remote work

100%

unannounced remote audit by Health Canada performed and PASSED. 

 

THE CHALLENGE

The current solution in place became an obstacle to company growth, pushes into additional markets, and a changing regulatory environment. 

THE SOLUTION

Zyris partnered with Greenlight Guru to upgrade their quality system to a platform designed for medical device companies coupled with an amazing customer experience.

THE RESULTS

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.

 

zyris

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

Morris Sherwood

 

 

“When we talk about implementing quality systems, it should be something you’re proud of. Starting out in medical device technology, you may have brilliant ideas, but you need to make sure you’re not going to do this on your own. Instead, surround yourself with smarter people who can change with you. There’s a lot of dependencies that occur in every part of a quality system. Greenlight Guru is a fantastic software because it addresses each one.”

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.

 

Challenge

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. 

 

Goals

  • Rebuild a quality system that would support their company growth and maintain compliance in global markets
  • Make compliance easy with a purpose-built platform 
  • See the inter-dependencies of their quality system and understand the impact of every decision made
  • Adapt with industry regulations and new norms of remote audits
  • Establish relationships with knowledgeable, industry experts 

 

Results

  • Implementing Greenlight Guru was seamless for Zyris as it felt natural and comprehensive.
  • Since going live, Zyris has successfully brought together critical processes and data into one single source. 
  • The modularity of the software allows their team to utilize the different modules one by one with an agile workflow to take each item and break it into smaller components - while keeping everything connected.
  • Zyris has now streamlined its ability to manage product quality processes: Post Market Surveillance and customer complaints.
  • While actively in the process of writing and modifying processes for full EU MDR implementation, Zyris has successfully navigated through several Notified Body audits.
  • Additionally, Zyris was surprised with a week-long unannounced audit from Health Canada, which was performed — and passed—remotely.
Learn more about Greenlight Guru and the ability to successfully navigate through regulatory changes and company growth.
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