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FREE on-demand webinar

Understanding the Medical Device Classification System: From Basics to Beyond — Using Classification to your Competitive Advantage

Watch the webinar

Many assume that the medical device classification system is a “no-brainer” and that classification is based simply on risk.  But reality is rarely so simple.

Average regulatory professionals know the rules – the best regulatory professionals know the exceptions!

In this webinar, Dr. Drues uses his unique tell don’t ask… lead don’t follow approach to demonstrate how to take control of your classification strategy and most importantly to use classification to your competitive advantage.

How does one determine the class of a medical device?  FDA’s classification database may help if you’re working on a me-too.  But what if you’re working on something new?  Or what if you want to change classification?

The regulatory logic you use is to make and defend your choice is critical.  Many companies have experienced long and costly delays in bringing devices to market because of classification mistakes, all of which could have could have been easily avoided.

Tune in to this free 90-minute presentation where you'll get the necessary tools you need to understand the classification system and more importantly to use it to your advantage!


Using a case study approach, all of these questions (and others) will be answered in an interactive fashion, including:

  • What is the medical device classification system?

  • Why do we have a classification system? Why is it important?

  • How do I determine classification?

  • Can I change classification?

  • How can I use classification to my advantage?

  • How does labeling influence classification?

  • How does risk influence classification?

  • How can the same device be class 0 (wellness), class I, class II or Class III?

  • How can I use classification to my advantage?

  • How does classification vary in other parts of the world?

  • What’s new in classification?

  • Q&A session

Participants will gain a clear understanding of device classification and learn best practices for approaching – and communicating with – the FDA.  Using case studies from a variety of clinical specialties, all of these and more will be discussed in this interactive webinar. Strategies for using regulation as a competitive advantage will also be discussed.

Who should attend?

  • Medical Device Executives

  • Regulatory Affairs Professionals and Management

  • Quality Professionals and Management

  • Clinical Affairs Professionals and Management
  • R&D Engineers and Management



Michael Drues, Ph.D.
Vascular Sciences



Jesseca Lyons
Medical Device Guru
Greenlight Guru




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.



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 developing effective communication strategies for companies and regulatory agencies to minimize time to market and avoid delays. His consultancy, Vascular Sciences offers a range of educational, training, and consulting services to medical device and biotechnology companies. Click here to learn more.