Obtaining regulatory market clearance and/or approval is a significant milestone for any medical device company, especially startups.
Navigating the various regulatory submission types and pathways from numerous global regulatory bodies can be a challenging pursuit for teams entering a new market for the first time.
Should a startup choose the European market first? Or is it more straightforward to pursue FDA for the US market to start? What are the deciding factors startups must consider when choosing between different markets to pursue?
Join the esteemed regulatory experts from the Greenlight Guru Regulatory Advisory Board for a lively panel discussion where we will compare and contrast FDA versus EU regulatory pathways (along with other sought after markets), discuss relative timelines and costs as well as the importance of clinical data, and other relevant topics.
Peter Sebelius
Founder and CEO
Medical Device HQ
Bassil Akra
CEO
AKRA TEAM GmbH
Allison Komiyama
Principal Consultant
AcKnowledge Regulatory Strategies
Michael Drues
President
Vascular Sciences
Tom Rish
Medical Device Guru Manager
Greenlight Guru
Jon Speer
Founder
Greenlight Guru
Become more confident in medical device product development. Join thousands of medical device professionals that take our highly-rated public and customized blended (online + live virtual), classroom and online courses in risk management, design control, project management, quality management, software development and safety for medical devices.
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AcKnowledge Regulatory Strategies specializes in Regulatory Affairs (RA) consulting exclusively for the medical device and In Vitro Diagnostic (IVD) industry. When you hire us, you also hire our entire network of current and former FDA reviewers, scientists, engineers, and regulatory/quality experts. We understand that each medical device needs a specific and tailored strategy to earn regulatory clearance. We strive to work with the FDA to ease the review process and get your device on the market faster than our competitors.
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AKRA TEAM is a consultancy company which was founded in 2021 by Dr. Bassil Akra to support the various stakeholders in the healthcare system achieving their target in a highly regulated business area. The focus of AKRA TEAM is to support medical device, in-vitro diagnostic and combination device innovators, companies, notified bodies and regulators finding a practical and reasonable approach to fulfill their legal obligations.
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Michael Drues, Ph.D., is a regulatory strategy consultant specializing in designing novel regulatory strategies to bring new and innovative medical products to market and in developing effective communication strategies between companies and regulatory agencies to minimize time to market and avoid delays.
His consultancy, Vascular Sciences is a consulting and training company offering a broad range of services to medical device, pharmaceutical & biotechnology companies including creative regulatory strategy & competitive regulatory intelligence, regulatory submission design, FDA presentation preparation & defense.
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Greenlight Guru is a modern quality management software platform used by medical device companies in over 25 countries to bring new products to market faster while simplifying regulatory compliance and reducing risk. Being the only industry specific, cloud-based eQMS, Greenlight Guru is easier to implement, easier to use and simply fits medical device processes out-of-the-box allowing companies to innovate faster and be more efficient.
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