RA/QA Today Podcast
1) The Aftermath Of MDR - Part III
In this final segment from 𝗧𝗵𝗲 𝗔𝗳𝘁𝗲𝗿𝗺𝗮𝘁𝗵 𝗼𝗳 𝗠𝗗𝗥 webinar, we discuss what you should and should not do when preparing for your certification, then segue into what you need to consider ...Show More
2) The Aftermath of MDR - Part II
Six months into MDR and manufacturers and notified bodies are clashing over differences in opinion and fighting over their respective interpretation of the standards in pursuit of product certificatio...Show More
3) The Aftermath of MDR - Part I
It's no longer a secret that MDR has morphed into an unmitigated disaster for the medical device industry - and Michelle has the goods to prove it. In this first in a series, she spills the beans on n...Show More
4) EUDAMED, MDR and Even More Madness with Richard Houlihan
This is the second part of my conversation with Richard Houlihan, where we delve into the current status of the EUDAMED database, the intricacies of the data entry process, and why the EU competent au...Show More
5) EUDAMED, MDR and Other Madness with Richard Houlihan - Part I
We all knew that MDR would change the medical device industry forever, hopefully for the better. But as manufacturers grapple with redundant requirements and notified bodies struggle to attract and re...Show More
6) The MDR No Good Very Bad Day: Go To Market Challenges in the EU
It used to be that Europe was the first choice when bringing a product to market. Relaxed regulation meant a quick approval and the chance to earn some money while waiting for FDA approval. That's not...Show More
7) The FDA No Good Very Bad Day: Common Regulatory Mistakes
Whether you are an investor or inventor/founder, there are some things you need to avoid if you want your FDA submission to succeed, some common regulatory mistakes that a lot of startups make. Thes...Show More
8) Empowering Female Entrepreneurs and Investors with Faz Bashi
More and more women are investing in medtech startups as the next phase of their professional development. It's a key career move that can fuel further business growth while establishing women entre...Show More
9) How A Strong Regulatory Strategy Can Boost Your Business with Stephanie Schull
Does regulatory strategy really impact your business strategy? Yes! Stephanie Schull, founder of kegelbell, explains how defining the regulatory strategy for her fledgling business early on helped pro...Show More
How A Strong Regulatory Strategy Can Boost Your Business with Stephanie Schull
19:56 | May 18th, 2021
10) FDA Submission Pathways with EIT Health Alumni
Determining which FDA submission pathway best applies to your medical device or product can be daunting. Listen in as Michelle explains how to decide if your product qualifies for a 510(k), PMA, de no...Show More