Search

Home > Medical Device made Easy Podcast > Real-World Evidence (RWE): How to Use It Right for FDA and EU MDR Compliance
Podcast: Medical Device made Easy Podcast
Episode:

Real-World Evidence (RWE): How to Use It Right for FDA and EU MDR Compliance
Category: Business
Duration: 00:00:00
Publish Date: 2025-10-23 00:01:41
Description:
MIniature Episode 359 Real-World Evidence (RWE): How to Use It Right for FDA and EU MDR Compliance Monir EL Azzouzi Easy medical device

Real-World Evidence (RWE) is transforming how regulators evaluate medical devices — but many manufacturers still struggle to use it correctly.

In this episode, we break down what RWE really means, how it differs between the FDA and the EU MDR, and how you can design a compliant, global strategy that turns data into regulatory strength.

You’ll learn:

  • What qualifies as Real-World Data (RWD) and Real-World Evidence (RWE)
  • How the FDA integrates RWE into premarket submissions (510(k), De Novo, PMA)
  • How EU MDR uses RWE through PMCF and PMS
  • The key differences in approach between the two regions
  • A practical 5-step roadmap to build a compliant RWE strategy
  • Common pitfalls (bias, poor traceability, privacy issues) — and how to avoid them

</td> </tr> <tr> <td> Total Play: </td> <td></td> <td> 0 </td> </tr> </table> </form> <audio controls autoplay style= Your browser does not support the audio element.