For quality and regulatory leaders at growing medical device companies, managing EU MDR and FDA 510(k) requirements simultaneously can feel like running two entirely separate compliance programs — with compounding documentation demands, divergent technical file structures, and tight timelines. This webinar cuts through the complexity with a practical, best-practice framework for building a unified compliance approach that satisfies both regulatory pathways without duplicating effort. We'll cover where EU MDR and 510(k) requirements converge and diverge, how to structure your QMS and technical documentation to serve both submissions, and common pitfalls that derail submissions.
Learning Objectives
- Identify where EU MDR and 510(k) requirements overlap and where they diverge so you can build a documentation strategy that serves both pathways efficiently
- Apply a unified QMS framework that satisfies both regulatory bodies without running parallel compliance programs or duplicating effort
- Avoid the most common pitfalls that delay or derail EU MDR and 510(k) submissions, from technical file gaps to design control misalignment
Who Should Attend?
Quality and regulatory leaders, VPs of Quality, Regulatory Affairs Directors, and senior compliance managers at medical device companies based in the US/UK/Canada/Ireland navigating complex submission requirements, whether preparing a first EU MDR or 510(k) submission, launching a new product indication, or managing dual-market compliance for an innovative device. Particularly relevant for companies in the 50–200 employee range where dedicated regulatory resources are lean but submission stakes are high.
Audience Learning Level
Intermediate: Content is designed based upon the assumption that individuals have basic knowledge of the topic(s) and/or demonstrated competence related to the topic(s). Higher-level concepts are introduced during lectures; exercises requiring synthesis and/or application of concepts are incorporated into the activity.
Proof of Attendance
A certificate of attendance can be downloaded from the RAPS Learning Portal following the event.
Questions
Contact the RAPS Support Center:
Call +1 301 770 2920, ext. 200 (8:30 am–5:30 pm EST, Monday–Friday) or email [email protected].
Speakers
Andrea Gallagher
Sumatha Kondabulu
