Indianapolis-based Greenlight Guru has formed a new regulatory advisory board. The company, which has developed a medical device quality management software platform, says the nine-member board will allow its customers to receive expertise in the evolving global regulations and requirements in the medical device industry.
Greenlight Guru says the members of the RAB have prior experience with regulatory bodies, including the U.S. Food and Drug Administration and European Union notified bodies. The board’s goal, according to the company, will be to provide the most up-to-date and best medical device industry intelligence regarding regulations and requirements.
“While global harmonization is an ideal for the medical device industry, regulations throughout the various markets are still dynamic and not always in sync,” Jon Speer, founder of Greenlight Guru, said in a news release. “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.”
The nine inaugural board members include:
- Dr. Bassil Akra – CEO and Co-owner of QUNIQUE GmbH
- Edwin Bills, ASQ Fellow, RAC – Consultant
- Dr. Michael Drues – President of Vascular Sciences
- Eric Henry – Senior Quality Systems and Compliance Advisor at King & Spalding
- Dr. Allison Komiyama, RAC – Principal Consultant at AcKnowledge Regulatory Strategies and former FDA reviewer
- Evangeline Loh – VP of Regulatory Affairs at EMERGO by UL
- Steve Niedelman – Lead Quality Systems and Compliance Consultant at King & Spalding
- Peter Sebelius – Founder of Medical Device HQ; CEO and Consultant at Gantus AB
- George Zack – Co-founder and Principal at Two Harbors Consulting; Lead Appraiser for FDA’s Case for Quality initiative
Greenlight Guru says the board will also serve as a forum to discuss current industry issues and trends, as well as identify needs for further education and information to help medical device companies and regulatory bodies.