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

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?

Watch the webinar

M.Drues webinar - 1-21-21
Using the case study approach, we’ll address these questions and more in an interactive fashion:
  • 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
Register Now  

Hosted by

M.Drues Headshot circle (3)
Presenter: Mike Drues

President, Vascular Sciences

Moderator: Jon Speer

Founder & VP QA/RA, Greenlight Guru


About Vascular Sciences
Vascular Sciences has been conducting seminars specifically geared toward medical device design, development and testing since 1996. These seminars have been requested by companies ranging in size from start-up to fortune 100 companies, the European Patent Office and the FDA Centers for Devices and Radiological Health (CDRH). Visit their website tolearn more.


About Greenlight Guru

Greenlight Guru is the only Medical Device Success Platform (MDSP) for companies to bring new products to market faster while simplifying regulatory compliance and reducing risk. Being the only industry specific, cloud-based software, Greenlight Guru is easier to implement, easier to use and designed to fit all medical device needs to enable innovative, safe and effective, True Quality medical devices. Visit our homepage to learn more.

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