Greenlight Guru Announces the Formation of Its New Regulatory Advisory Board

Leading medical device QMS provider establishes Regulatory Advisory Board comprised of global regulatory experts

INDIANAPOLIS — May 27, 2021 — Greenlight Guru, the leading medical device quality management software platform, today announced the formation of its new Regulatory Advisory Board (RAB), comprised of nine veteran medical device professionals. Members of Greenlight Guru’s RAB have prior experience with regulatory bodies, including FDA and EU notified bodies, and have significant medical device industry expertise with respect to regulations, standards, and requirements impacting the medical device industry.

Medical device industry regulations, standards, guidelines and requirements evolve often, and expectations for medical device companies are increasing and ever-changing. Now more than ever, companies need guidance and solutions to navigate frequent industry changes on a global scale.

"While global harmonization is an ideal for the medical device industry, regulations throughout the various markets are still dynamic and not always in sync,” said Jon Speer, founder of Greenlight Guru. “The regulatory changes continually impact our industry. As such, Greenlight Guru is continuing to push the ideal of harmonization and industry best practices forward through the formation of our Regulatory Advisory Board."

Collaborating with external medical device regulatory experts helps ensure Greenlight Guru, its customers, and the entire medical device industry have a channel for receiving the most up-to-date and best medical device industry intelligence regarding global regulations and requirements. As a result, Greenlight Guru products and services will not only continue to comply with the latest requirements but also stand out as best-in-industry entries. Greenlight Guru RAB members are actively involved with influencing and defining the regulations, standards, and requirements that impact medical device companies around the world. The RAB is a forum to discuss current industry issues and trends and identify needs for further education and information to help medical device companies, as well as regulatory bodies.

“This group has the potential to influence the direction of the medical device industry in some very significant ways,” said Greenlight Guru RAB member, Michael Drues, PhD, President of Vascular Sciences. “I look forward to being part of those discussions as we work to make the medical device industry and indeed the world a better place.”

The first nine members of Greenlight Guru’s RAB are:

• Dr. Bassil Akra - CEO and Co-owner of QUNIQUE GmbH; EU MDR / IVDR expert

• Edwin Bills, ASQ Fellow, RAC - Consultant; 20-year Member, ISO TC 210 JWG1, the technical committee responsible for ISO 14971:2019 and ISO TR 24971:2020.ISO 14971 Standard Development Team Member

• Michael Drues, PhD - President of Vascular Sciences; expert in regulatory strategies, including FDA De Novo, 510(k), and breakthrough device program

• Eric Henry - Senior Quality Systems and Compliance Advisor at King & Spalding; expertise with software as a medical device (SaMD), AI and machine learning

• Allison Komiyama, PhD, RAC - Principal Consultant at AcKnowledge Regulatory Strategies; former FDA reviewer and expertise with FDA breakthrough device program and 510(k) submissions

• Evangeline Loh - VP of Regulatory Affairs at EMERGO by UL; experienced with global regulatory processes

• Steve Niedelman - Lead Quality Systems and Compliance Consultant at King & Spalding; expertise with FDA inspections, including post-inspection followup

• Peter Sebelius - Founder of Medical Device HQ; CEO and Consultant at Gantus AB; Member, ISO TC 210 JWG1, the technical committee responsible for ISO 14971:2019 and ISO TR 24971:2020.

• George Zack - Co-founder and Principal at Two Harbors Consulting; Lead Appraiser for FDA’s Case for Quality initiative

To stay up to date with the Greenlight Guru Regulatory Advisory Board, subscribe to our newsletter www.greenlight.guru/newsletter.

For more information about Greenlight Guru’s solutions, visit: https://www.greenlight.guru/.