Greenlight Guru Announces Nationwide Medical Device Quality & Regulatory Roadshow

Tuesday, January 29, 2019 General News
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True Quality Roadshow will gather leading quality, regulatory and product development professionals to educate on the changing regulatory paradigm

INDIANAPOLIS, Jan. 29, 2019 /PRNewswire-PRWeb/ -- Greenlight Guru, the only quality management software platform

designed specifically for medical device companies, today announces their 2019 True Quality Roadshow, a seven city, countrywide gathering of medical device professionals and industry stakeholders.

The True Quality Roadshow will include a networking event and panel discussion consisting of industry professionals, as well as a fireside chat with Greenlight Guru founder and VP and QA/RA, Jon Speer, on the current state of the medical device industry, regulatory updates and best practices in attaining "true quality."

"The True Quality Roadshow aims to become a leading destination for the exchange of best practices, venues for networking and career growth, and the celebration of industry embracing Quality," said Speer. "Coming off the heels of our partnership with FDA to help promote the benefits of their Case for Quality initiative, the Roadshow furthers our mission to help improve the quality of life by helping device makers imagine, introduce and advance higher quality devices faster, with less risk."

The Case for Quality program provides a conduit for FDA to work with stakeholders —manufacturers, healthcare providers, patients, payers and investors— to shift focus from a regulatory-only stance, to a focus on quality maturity. The Case for Quality Pilot Program saw great success in 2018.

"Participants have sailed over the compliance bar," said Cisco Vicenty, FDA Case for Quality Program Manager, at a recent MDIC Case for Quality Forum.

The FDA partnered with Greenlight Guru earlier this year to share lessons learned from the Pilot program, including what worked and what the next steps are, in a four-part webinar series hosted by Speer and Vicenty.

"Forward-thinking initiatives require forward-thinking partners," said Vicenty. "We are encouraged by Greenlight Guru's nationwide efforts to help support the vision of the Case for Quality: to move the medical device ecosystem from a mindset of compliance to a broad culture of quality."

The True Quality Roadshow will be hosted in leading medical device hubs across the country. The first stop of the roadshow will be Atlanta, Georgia in March 2019.

  • Atlanta, Ga. – March
  • Boston, Mass. – April
  • Minneapolis, Minn. – May
  • San Francisco, Calif. – July
  • Houston, Texas – August
  • Orange County, Calif. – Oct
  • San Diego, Calif. – Nov

The True Quality Roadshow follows the announcement of their webinar partnership with the FDA and Multi-Level Design Control and Advanced Document Management product announcements.

To learn more about the attending the roadshow in a city near you and partnership opportunities, please visit

About Greenlight Guru Greenlight Guru is the only quality management software platform designed specifically for medical devices companies. The platform helps companies bring safer products to market faster, simplifies FDA and ISO regulatory compliance and provides a single source of truth by connecting the management of all quality processes like CAPAs, risk, audits and more. Greenlight Guru's platform is used by thousands of users across the globe to push beyond baseline compliance and achieve True Quality for their medical devices. For more information, visit


SOURCE Greenlight Guru

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