5 QMS Elements that must Connect to your Design Control for an Effective, Audit Proof Process

Design Controls are a set of quality practices and procedures which govern medical device design.

They are promulgated in 21 CFR 820.30 of the Quality System Regulation and are intended to ensure that user needs and intended uses are met and that finished devices are safe and effective for their intended use.

An effective Design Control system connects key Quality Management Subsystems and impacts not only pre-market design and development, but also impacts post market device management.

This webinar will begin with a brief overview of Design Controls followed by the 5 key QMS subsystems that when connected to the Design Control process create an effective audit proof Design Control system. You will also discover the roll that these key connections play in post market vigilance activities and the one “must have” tool to aid in the process.

Watch the webinar

Specifically, this webinar will cover:
  • Overview of Medical Device Design Controls
  • 5 Key QMS Subsystems that must connect to the Design Control Process
  • The role these key connections play in post market vigilance activities
  • The one “must have” tool to aid in making these critical connections
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

Presenter: Wayner Williams, CQA

Quality and Regulatory Professional, Medpoint LLC

Moderator: Jon Speer

Founder & VP QA/RA, Greenlight Guru


About Medpoint
In keeping with our mission, the Center for Devices and Radiological Health (CDRH) is responsible for protecting and promoting the public health. We assure that patients and providers have timely and continued access to safe, effective, and high-quality medical devices and safe radiation-emitting products. We provide consumers, patients, their caregivers, and providers with understandable and accessible science-based information about the products we oversee. We facilitate medical device innovation by advancing regulatory science, providing industry with predictable, consistent, transparent, and efficient regulatory pathways, and assuring consumer confidence in devices marketed in the U.S.

We seek to continually improve our effectiveness in fulfilling our mission by planning strategically and regularly monitoring our progress. 


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.

Featured In