Attend Our Upcoming Webinar

On Tuesday, 8 Nov. at 11 a.m. ET, RQM+ will host a webinar: “Common FDA and Notified Body Software Deficiencies and How to Avoid Them.” Fill out the form to register now.

What You Can Expect to Learn

Software changes frequently — and so do the expectations from regulatory authorities about the information required to support software. Well-defined indications and proper classification of the risk related to the software are crucial to setting the stage for the information required in the submission. Add in proprietary algorithms based on datasets, the use of off-the-shelf software, various amounts of clinical data and interconnectivity with other devices, and there is no doubt that software is going to get a lot of scrutiny in the regulatory approval process.

In this webinar, we briefly explore common findings from notified bodies and the U.S. Food and Drug Administration (FDA) and how you can avoid them!

Notified bodies and the FDA expect to see complete software documentation, but the following items can trip up even the most seasoned regulatory professional submitting a safe and effective device for review:

  • Inconsistency in the risk classification
  • Failure to follow the most current or active guidance
  • Not clearly mapping the requirements to the documents that are included
  • Inadequate clinical data

Using the collective knowledge from our entire team and hundreds of submissions, this webinar will provide the most common findings related to software:

  • FDA’s most common software findings
  • NB findings in technical file reviews
  • Post-market considerations

Learning Level

Intermediate: Content is designed based upon the assumption that individuals have basic knowledge of the topic(s) and/or demonstrated competence related to the topic(s). 

Meet the RQM+ Experts:

Nancy_Morrison_1-min-429968-editedNancy Morrison, RAC
VP, Intelligence & Innovation

Nancy has more than 30 years of quality and regulatory experience in the medical industry with U.S. and global regulatory submission experience. She has spent the last nine years with RQM+, working with startup, mid-size and multinational medical device and combination product companies. Nancy has been providing EU MDR and IVDR leadership in developing solutions and implementing the regulations at small and large organizations.

Ashley (Ash) ClarkAshley (Ash) Clark, MS, RAC
U.S. and Medical Device Principal Specialist

With 10 years in pre- and post-market regulatory roles, Ash has deep experience with MDR and IVDR remediation support and providing strategic solutions for EU regulatory compliance, including addressing the impact of Brexit.

 

Fill out the form to register for the webinar