Watch Our On-Demand Webinar

On Tuesday, 8 Nov., RQM+ subject matter experts hosted a webinar, “Common FDA and Notified Body Software Deficiencies and How to Avoid Them.” Fill out the form to get access to the on-demand recording now.

What You Will 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:

Kevin Go, MBA, RAC, CQA
Senior Principal, Regulatory and Quality Practice

Kevin is Senior Principal of Regulatory and Quality Practice at RQM+ and helps clients navigate U.S. and EU regulations. Before RQM+, he worked at the FDA for more than 5 ½ years, serving as a Lead Reviewer in the Division of Orthopedic Devices, where he reviewed numerous pre- and post-market submissions. Additionally, Kevin served as an Advisor to the CDRH Innovation group and Payor Communication Task Force, where he provided early regulatory and reimbursement assistance to small businesses.

Hrishikesh Gadagkar
Principal Engineer

As a Principal Engineer, Rishi helps to provide clients with industry-leading regulatory and quality consulting services throughout the entire product lifecycle. Rishi has worked at several large, mid-size and smaller start-ups where he was leading engineering and Manufacturing functions. He has launched several medical devices that were software controlled and some incorporated machine learning algorithms. Rishi brings deep understanding of requirements for implementing high-quality software systems that are reliable and secure.