Juan Carlos Serna teamed up with greenlight.guru's Jon Speer to produce the podcast, "Why the 510(k) Process Is So Stressful & How You Can Help Streamline It." The episode discusses why the 510(k) process is old fashioned and in need of some upgrading, and how Right Submission can make your next 510(k) submission less painful by leveraging software to work faster and smarter.
Right Submission will attend the 2017 RAPS Regulatory Convergence in Washington DC September 11-12. We are at Table 14--please come see us and get a demo of our software offerings.
Wednesday, September 27, 2017 @ 12:00 pm - 1:00 pm
We have teamed up with MassMEDIC and FDA Attorney Jeffrey N. Gibbs of Hyman, Phelps & McNamara, P.C. to bring you a webinar focused on legal questions you might have relative to FDA product submissions.
Questions such as:
- From a legal perspective what are common mistakes submitters make in FDA submissions?
- What recent legal cases has CDRH been involved in and how have they turned out?
- Is the confidentiality text we copy/paste into our submissions legally binding and what happens if we don’t include it? When should we include it?
This is an extraordinary opportunity to get your legal questions about FDA device submissions answered.
Right Submission is pleased to announce the release of the CER platform. Contact us for a demo to learn how Right Submission can help streamline your CER workflow.
Right Submission is pleased to announce the release of the Knowledge Management System. Contact us for a demo to learn how Right Submission can help manage your regulatory document library.
In April 2017 FDA cleared a 510(k) submission prepared with Right Submission's 510(k) platform in just 54 days. This is 3.2x faster than the average FDA clearance time and 123 days faster than average. Imagine what obtaining clearance for your device 123 days sooner could do for your company.
Another 510(k) prepared with Right Submissions 510(k) platform has been submitted to the FDA.
Right Submission ‘s workshop “Next Generation Tactics for 510(k) submissions” was well received with over 25 attendees in person and online. If you missed the workshop and would like a recap, please let us know!
Right Submission is pleased to announced that the second 510(k) submission prepared utilizing its 510(k) platform has been submitted to the FDA. This submission has successfully passed FDA’s administrative acceptance review and has moved onto the substantive review.
Right Submission announces an upcoming event at 12pm on March 9, 2017 at the Cambridge Innovation Center in Cambridge, MA for the Massachusetts medical device community.
Right Submission is pleased to announced that the first 510(k) submission prepared utilizing its 510(k) platform has been submitted to the FDA. This submission has successfully passed FDA’s administrative acceptance review and has moved onto the substantive review.