Greenlight Guru Partners with ICS and Two Harbors Consulting to Bring Nationwide Medical Device Quality & Regulatory Roadshow to Minneapolis

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True Quality Roadshow to gather leading quality, regulatory and product development professionals to educate on the changing regulatory paradigm

True Quality Roadshow
The Roadshow furthers our mission to help improve the quality of life by getting the world’s leading medical experts into one room to discuss the importance of high-quality medical devices.

Greenlight Guru, the only medical device quality management system (MD QMS) software platform, is bringing their 2019 True Quality Roadshow, a seven-city, countrywide gathering of medical device professionals and industry stakeholders, to Minneapolis on June 13 at the Watson Block Event Center & Venue.

The True Quality Roadshow will comprise of a networking event and panel discussion consisting of seasoned industry professionals including Milton Yarberry, Director of Project Management at Integrated Computer Solutions. The evening event also consists of a fireside chat with Jon Speer, founder and VP of QA/RA at Greenlight Guru, and George Zack, Principal and Co-founder at Two Harbors Consulting, on the current state of the medical device industry. The panel will discuss regulatory updates and best practices to attaining medical device “True Quality,” including the current state of the new European Union Medical Device Regulations (EU MDR).

“The True Quality Roadshow is an opportunity for industry professionals to come together to network, exchange best practices and prepare for upcoming regulatory changes,” said Speer. “The Roadshow furthers our mission to help improve the quality of life by getting the world’s leading medical experts into one room to discuss the importance of high-quality medical devices.”

With the FDA’s Case for Quality program, the True Quality Roadshow works with key stakeholders —manufacturers, healthcare providers, patients, payers, and investors— to shift focus from a compliance stance, to a focus on quality maturity.

“High-performance medical device manufacturers view quality as a product feature, not a regulatory hurdle,” said Zack. “The True Quality Roadshow furthers the mission of the FDA’s Case for Quality by providing medical device professionals with real-world business cases of quality systems yielding quality devices.”

“Greenlight Guru and Two Harbors Consulting share a core mission – improving the quality of life through safe and effective medical devices,” said Zack. “Improved device quality, true quality, is central to that mission.”

The True Quality Roadshow will be hosted at Watson Block located at 256 North 1st Ave in Minneapolis, Minn. with additional events throughout the year in leading medical device hubs across the country.

  • San Francisco, Calif. – July 11th
  • Houston, Texas – August 29th
  • Orange County, Calif. – Oct
  • San Diego, Calif. – Nov

The Minneapolis True Quality Roadshow follows the announcement of Greenlight Guru being named the sole leader in the Quality Management Software category by G2 Crowd as well as the launch of their MedTech True Quality Stories podcast.

To learn more about 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 device 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

About ICS
At the intersection of custom software development, engineering and UX design, Integrated Computer Solutions (ICS) has been helping Fortune 1000 companies create transformational products for over 30 years. It has developed countless modern user interfaces, connected products and touchscreen-enabled applications for global companies like Boston Engineering, Boeing and Intel; everything from agriculture equipment, defibrillators and commercial kitchen appliances, to air traffic control, self-driving autos and in-vehicle infotainment (IVI) systems.

About Two Harbors Consulting
The Two Harbors Consulting Team holds over 50 years combined experience in process and performance improvement, and organizational change management and nearly 100 years of combined experience in software development and services delivery. Two Harbors Consulting staff are certified to perform appraisals and training for CMMI for Development, Services, as well as High Maturity appraisals.

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