RND Group Presenting at Greenlight Guru TRUE QUALITY Virtual Summit
Ready to get your products or instruments to the market faster while staying in front of regulatory requirements?
Greenlight Guru is hosting a True Quality Virtual Summit that is a 3-day, 3-track, must-attend experience for medical device quality, regulatory, and product development professionals who drive innovation in the most well-respected, high-performing companies in the market today.
The RND Group is excited to announce that we will be presenting on Strategies for ensuring a Medical Device released under EUA will stay on the market after EUA expires.
In light of the current environment, this will be a 100% virtual opportunity.
The Greenlight Guru True Quality Summit will take place June 2-4, 2020.
HERE’S WHAT YOU CAN EXPECT TO TAKE AWAY FROM OUR PRESENTATION:
- EUA approval is truly temporary and once EUA approval expires, a product must be removed from the market if it is not otherwise approved or cleared
- In parallel to EUA, a “normal” FDA submission should be prepared and submitted under 510(k), PMA, or other regulatory approval pathway
- Assessing the design and development approach used for an EUA-approved device will identify gaps to be addressed to prepare a “normal” submission
- Companies without prior successful FDA submission experience are most at risk for not being prepared and for not receiving a timely approval of a follow-up submission after their EUA expires
Register today to secure your spot to learn from the comfort of your own home!