June 2019 Chapter Meeting – SE & EU Medical Device Regulations
The European Union has released a sweeping Medical Device Regulation (MDR) that goes into effect for all Medical Devices sold in Europe, next year. This presentation will discuss the unique role of systems engineering in the management of documentation required by the MDR Technical File. We will discuss how to plan a technical file transitions to the MDR, “state of the art” and some new requirements that have a large impact. The MDR expands on ISO-14971 with related requirements for benefit-risk analysis, clinical evaluation, and post market surveillance. Last and certainly not least, we will discuss the issues related to labeling requirements changes.
TOPIC: SE & EU Medical Device Regulations
SPEAKER: Jamie Roman
AGENDA
(all time CT)
6:00 - 6:30 pm - Dinner & Networking
6:30 - 6:45 pm - Introductions & Announcements
6:45 - 8:00 pm - Presentation and Q&A
8:00 pm - ??? - Additional Networking
LOCATIONS:
We offer multiple locations throughout the Chicagoland area and online. Visit the Chapter registration page to see which locations are available this month.
EVENT REGISTRATION:
Event Registration