Live! #34 — Optimizing Technical Documentation to Reduce Notified Body Review Time and Questions (Devices & IVDs)

This is the audio-only version of RQM+ Live! #34, originally recorded May 6, 2021.

We all have the same goals when submitting technical documentation to the notified body for review:

• Minimize questions
• Minimize deficiencies
• Achieve certification

There are many strategies to improve your odds, and this panel of experts knows them well. We'll discuss the easy solutions, such as simply using terminology and organizing your file in a way that the notified body reviewers expect. This may sound obvious, but we've all worked at manufactures who wanted their regulatory files to be different than recommended.

We'll also discuss more complicated but necessary strategies, like telling a consistent story of clinical evidence across promotional claims, risk management, clinical evaluation, and post-market surveillance.

Many of us like to use the metaphor that while you may all be wonderful singers individually, if you are each singing from different sheet music... well, it will sound awful to the audience.

This panel of subject matter experts includes our esteemed former notified body leaders as well as our seasoned regulatory professionals who have created many MDD and MDR technical documentation files. No matter how long you've been in the industry, we believe that you'll leave this discussion with some new tips and tricks to take back to your team.

Panelists:

• Jaishankar (Jai) Kutty, Ph.D. - VP, Clinical Regulatory Services
• Nancy Morrison, RAC - Executive Director, Regulatory and Quality Consulting Services
• Ruthanne Vendy, RAC - Senior Principal Specialist
• Melissa DeHass - Senior Regulatory Specialist