The FDA Pre-Submission process is one the most effective tools out there to de-risk your 510(k) yet it is often both under-utilized and used improperly.
The Pre-Sub allows for device manufacture to discuss and get feedback directly from FDA on both their product development and regulatory strategy.
When used properly the Pre-Sub process can result in significant time savings to market - however when used improperly or ignored all together, this can easily result in unnecessary delays and wasted money.
Join us for this free 90 minute webinar co-presented by David Amor, a leading medical device QA/RA expert, and Jon Speer, founder and VP of QA/RA at greenlight.guru, where the two will show you how to prepare and make the most of your Pre-Sub and also walk you through a step-by-step case study of the process.
Medical Device Executives
Regulatory Affairs Professionals and Management
Quality Professionals and Management
Clinical Affairs Professionals and Management
R&D Engineers and Management
Note: Limited live seats available
Greenlight Guru is the only Quality Management Software Platform built exclusively for the unquie needs of medical device companies, allowing you to bring safer devices to market faster while reducing risk and ensuring compliance. Go here to learn more.