Episode Details

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

We are passionate about your success. Tell us more about your regulatory and quality needs so we can help.

Book a Consultation

GLOBAL BOTTOM CTA INSTRUCTIONS:

To display custom copy instead of global copy in this section, please go to Show Global Content for Bottom CTA? toggle in the "Contents" tab to the left, toggle it off, save, and then REFRESH the page editor, the custom text will then show up and ready to be edited.

Turning the global content back on will be the same process, go to the toggle and toggle it back on, save and refresh!