Free On-Demand webinar

FDA vs. EU Regulatory Pathways: Factors Every Startup Must Consider with Go-to-Market Strategy

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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.


Specifically this webinar will cover:

  • Similarities and differences between regulatory pathways in US vs EU markets, and others
  • FDA pre-submission process
  • EU requirements for clinical data
  • Startups and/or companies new to medical device industry (i.e. EUA)
  • Go-to-market timeline constraints
  • Notified bodies: non-responsive or ambiguous
  • FDA clearance / approval becoming gateway for other markets

Who should attend?

  • Medical Device Executives
  • Regulatory Affairs Professionals and Management
  • Quality Professionals and Management
  • R&D Engineers and Management



Peter Sebelius

Peter Sebelius
Founder and CEO
Medical Device HQ

Bassil Akra

Bassil Akra

Allison Komiyama

Allison Komiyama
Principal Consultant
AcKnowledge Regulatory Strategies

Mike Drues

Michael Drues
Vascular Sciences


Tom Rish
Medical Device Guru Manager
Greenlight Guru



Jon Speer
Greenlight Guru

ABOUT Medical Device HQ

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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ABOUT AcKnowledge Regulatory Strategies

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.

Visit their website to learn more.

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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.

Visit their website to learn more.




ABOUT the presenter

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.

If you'd like to learn more click here.

About greenlight guru

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.

Visit our homepage to learn more.