Podcast – Streamlining the MDSAP device marketing authorization and facility registration process

By
James Gianoutsos
-
August 23, 2020
Podcast – Streamlining the MDSAP device marketing authorization and facility registration process

I had the opportunity to sit down with Jon Speer, Founder & VP of QA/RA at Greenlight Guru to record a podcast to discuss streamlining the MDSAP Marketing Authorization & Facility Registration Process.

If you are not familiar with this topic, you need to hear this.

We discuss:

  • Why your regulatory team may be perceived as a bottleneck and why it is important everyone needs to be on the same page about when the product can be released.
  • The connection between marketing authorization and facility registration required for various countries – United States, European Union, or elsewhere.
  • The need to get organized, get better systems in place, and stay compliant when an auditor comes through your door or when you plan to sell into markets.
  • Why small and large companies need to get organized now (i.e. small companies have too much information to maintain, organize, and track while large companies may have resources but suffer from miscommunication and disjointed processes.)
  • The need to not be complacent and not be afraid to change systems. Rimsys was created to help regulatory professionals successfully and efficiently handle documentation.

You can hear the podcast below or at the Greenlight Guru blog.

Similar posts

PSUR: Post-market surveillance reporting for medical device and in vitro diagnostic products
PSUR: Post-market surveillance reporting for medical device and in vitro diagnostic products
De Novo Classification Process: A Beginner's Guide
De Novo Classification Process: A Beginner's Guide
GUDID: An overview of the FDA's Global Unique Device Identification Database
GUDID: An overview of the FDA's Global Unique Device Identification Database