Greenlight Guru takes its show on the road

Quality-management software company Greenlight Guru said it will stage a nationwide medtech quality and regulatory “roadshow” beginning in March.

The seven-city “True Quality Roadshow” series is designed to educate quality, regulatory, and product development professionals on the changing regulatory paradigm in the medtech industry, according to Indianapolis-based Greenlight Guru.

Each event will include a networking session  and panel discussion consisting of industry professionals, as well as a fireside chat with Greenlight Guru founder Jon Speer on the 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 in a prepared statement. “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 programs allows FDA to work with stakeholders in the healthcare industry, such as manufacturers, healthcare providers, patients, payers, and investors. Introduced in 2011, the program was designed to move the focus from regulatory-only to a collaborative industry partner by recognizing manufacturers that are consistently making high-quality devices.

Since its launch, FDA has created programs for stakeholder engagement and has developed a Voluntary Manufacturing and Product Quality appraisal pilot and is also piloting streamlined submission reviews to support improvement. The agency is also working on clearing real or perceived regulatory approaches that could be barriers to quality.

“Participants have sailed over the compliance bar,” said Cisco Vicenty, FDA Case for Quality program manager, at a recent Medical Device Innovation Consortium Case for Quality forum.

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.

The True Quality Roadshow will be hosted in leading medical device hubs across the country. Cities on the tour include:

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

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