Right Submission Exhibiting at 2018 RAPs Convergence

Right Submission is exhibiting at the upcoming 2018 RAPS Regulatory Convergence in Vancouver, October 2 - 4. We will be showcasing our suite of SaaS-based regulatory submission solutions.

Stop by our booth in the exhibition hall for a demo of our current offerings, and ask for a preview of our upcoming products in development. Looking forward to seeing you there.

Right Submission announces the launch of our Regulatory Intelligence module.

Here you can search our proprietary database of over 147,000 FDA-cleared 510(k)s and De Novos, including the first available Indications for Use search tool, which is invaluable for both regulatory work and competitive analysis. 

  • You can search via Keyword or Indications for Use to return results specific to your product, and view Indications for Use results right in the browser.
  • You can add additional parameters to refine your search as you go, so once you've executed an Indications for Use search, you can filter by a specific Product Code, Review Panel, or Regulation.
  • You can save searches and return to the platform to update results or explore alternative regulatory pathways.

 

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Right Submission launches our Regulatory Foundations Module

This free tool allows the experienced and novice user to assess and document their medical device FDA regulatory pathway decision making process and supports regulatory strategy development.

The tool includes access to our proprietary database of >147,000 FDA regulated medical devices and introduces a documentable search of the Indications for Use in our database - the first available IFU search tool which is invaluable for both regulatory work and competitive analysis.

Right Submission at the Medical Device Technology Exchange Conference and Exhibit in Seacaucus, NJ

Right Submission and Greenlight Guru will be hosting a workshop, 510(k) Best Practices: Applying Risk Management and Design Controls. 

In this workshop you will learn a step-by-step approach for identifying the regulatory pathway, testing requirements and verifying these requirements before you even begin your testing. This is all part of an integrated approach to planning of design and risk management for medical devices.

You can learn more about the workshop, and register for the event, by clicking here.

Right Submission Announces the Release of our CSR Product

This software guides you through the creation of a CSR pursuant to the ICH E3 guidelines for Clinical Study Reports. It helps build high quality content and allows for easy integration and management of your clinical data analysis and Section 16 appendices. You can then seamlessly merge your completed CSR into the 510(k) platform for premarket clearance.

Upcoming MassMEDIC Webinar: FDA Medical Device Submissions – You’ve Got Legal Questions – We Have the Expert

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.