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When Design Input Requirements Go Wrong

Watch the Free Webinar

Design inputs are the foundation of medical device development.

And without a strong foundation, bringing a new product to market can be problematic.

"Getting your design inputs right is the most important thing you can do to make sure your device is developed correctly." -Jon Speer 

According to the FDA’s design controls guidance, design inputs can take up as much as 30% of the project timeline for complex designs. 

In this free 60 minute webinar, Jon Speer, Greenlight Guru founder and VP of QA/RA, will walk through common mistakes device companies make when defining design requirements and best practices to avoid them. 

Specifically This Webinar Will Cover: 

  • Examples of Common Mistakes 
  • Design Input Requirements for FDA 21 CFR 820 and ISO 13485:2016
  • The Art of Defining Design Inputs
  • Sources For Design Inputs
  • Best Practices for Becoming A Design Input Artist
  • Real-life Example Case Study
  • Q&A Session

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


About the presenter:


Jon Speer is the founder and VP of QA/RA at Greenlight Guru and the main contributing author of this publication. Jon is a medical device industry veteran with over 20 years experience having helped dozens of devices get to market over his career in a variety of roles including product development, project management, quality and regulatory. He is a thought leader, speaker and regular contributor at numerous leading industry publications. He is also the host of the #1 most downloaded podcast in the industry, The Global Medical Device Podcast.



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 home page to learn more.



Jon Speer
Founder & VP QA/RA
Greenlight Guru