Beyond Design Controls 101: Following the Regulation vs. Understanding its Intent

Since 1990, FDA has required medical device manufacturers to follow design controls. Outside the US, the EU MDR (formerly MDD) include similar requirements as well. 

Yet, although manufacturers have design control processes in place, they are not always effective as failure to follow design control requirements is commonly cited in FDA 483’s and warning letters. 

Clearly just having design controls in place and understanding what the regulation says is not enough!

We must also understand what design controls are trying to accomplish, i.e., why they exist, in order to avoid problems.

At the end of the day, design controls should not be about a hard and fast set of rules… rather, it’s about understanding the intent and approaching the process in a logical and systematic fashion. In other words, don’t just follow the rules… think!

Watch the webinar

MDrues webinar - 4-2-20
Using the case study approach, participants will gain a working understanding of:
  • What are design controls and why do we have them?
  • Who is required to follow design control processes and who is not? What if no design control system?
  • How early in the development process do design controls apply?
  • How do we control the design process without actually “controlling” it?
  • How do we take a holistic approach? i.e., integrate design control, risk management, CAPA, etc.
  • What happens if we modify a design or process?
  • What does FDA look for in a design control system?
  • How do design controls apply to combination products?
  • What are the design control challenges for the future, i.e., 3-D printing, etc.?

Upon completion of this webinar, attendees will have an understanding of the design control “framework” and recommendations to effectively meet their requirements.

Emphasis will be placed not only on regulatory aspects but on effective design strategy, which is very important to avoid spending unnecessary time and money on an ineffective design control process.

Who Should Attend?
  • Medical Device Industry Executives
  • Quality Professionals and Management
  • Regulatory 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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