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FREE On-demand webinar

Change Management and Risk Management: How do we connect the dots and what happens if we don’t?

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Change management and risk management are among the most important and most commonly discussed topics in the medical device industry today.

Yet in spite of that, or perhaps because of that, change management and risk management remain the “root cause” of the most common problems medical device companies experience, often leading to FDA 483 observations, warning letters or worse! Why?

Most medical device development is evolutionary, i.e., design and test a device, get it thru FDA, sell the device… then change the device and repeat. This doesn’t often happen in the drug world, but it happens in the medical device world all the time!

Medical device companies are “required” to have quality management systems in place with detailed policies and procedures on change management and risk management. But are these components integrated, or do they exist in isolation, and does one talk to the other?


Using the case study approach, these questions and others will be presented in an interactive fashion, including:

  • How do we integrate change management and risk management?
  • How do we assess, implement and validate change in the context of risk?

  • Which changes necessitate risk evaluation and which do not?

  • How does change management and risk management vary pre-market vs. post-market?

  • What if your device is capable of changing (evolving?) by itself (i.e., artificial intelligence)?

  • What are the consequences of not integrating change management and risk management?

  • Q&A session


In this webinar, Dr. Drues uses his unique tell don’t ask… lead don’t follow approach to demonstrate how to integrate change management and risk management and will share best practices using case studies from a variety of clinical specialties in this interactive webinar.

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



Jon Speer
Founder & VP of QA/RA
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 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.