Design controls are consistently, year after year, one of the top reasons device makers receive FDA 483’s and warning letters, yet, this doesn’t and shouldn’t be the case.
Indianapolis, IN (PRWEB) June 01, 2017
greenlight.guru, the only modern quality management software platform exclusively for medical device companies, today announced that its founder and VP of QA/RA, Jon Speer, will be chairing the Design Control Track at the upcoming MD&M East in New York City, NY at the Javits Convention Center on Wednesday, June 14th, 2017.
greenlight.guru also announced today that its Customer Success Expert, a medical device product development engineer with nearly a decade of industry experience, Jesseca Lyons, will be giving a presentation at the conference on the topic of “When Design Input Requirements Go Wrong.”
Her presentation will take place on Wednesday, June 14th from 9:10am - 9:50am and specifically will cover:
- Exploring examples of insufficient design input requirements
- Considering the consequences of poor design input requirements
- Why getting design input requirements correct is critical and how to do it right the first time
“Design controls are consistently, year after year, one of the top reasons device makers receive FDA 483’s and warning letters, yet, this doesn’t and shouldn’t be the case,” said Mr. Speer. “So being asked to chair the design control track at MD&M East, the largest and most influential medtech event on the east coast, provides a great platform to continue to educate the industry on best practices around design controls and risk management.”
Through both their educational content and award winning design control software, greenlight.guru continues to advance their mission of improving the quality of life by helping medical device companies bring safer devices to market faster with less risk while simplifying compliance.
To get more information about all the presentations that will be apart of the MD&M East 2017 Design Control Track taking place on Wednesday, June 14th at the Javits Convention Center in New York City, please go here.
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. Device makers across the globe are replacing their outdated paper-based and general purpose legacy quality systems with greenlight.guru. Being the only modern industry specific, cloud-based eQMS, greenlight.guru is easier to implement, easier to use and simply fits medical device processes better allowing companies to innovate faster and be more efficient. For more information or to demo our software, please visit http://www.greenlight.guru.