6 December 2018
11:00 – 4:00 pm EST
Registration
Information
Webcast registration includes access to handouts, presentation slides and the on-demand recording for one year.
RAPS Members: $ 499
Nonmembers: $ 575
The new European Medical Devices
Regulation (MDR) was published in May 2017 to improve the safety and efficacy
of medical devices in the EU. This regulation replaces two of the existing
medical device directives by 2020. The transition window for compliance with
MDR is rapidly closing, manufacturers need to be making urgent progress in
addressing changed requirements and generating supporting evidence needed to
for both new and existing legacy CE Marked AIMD/MDD devices. Regulatory affairs
professionals with responsibility for European devices can’t afford to wait
until all the supporting guidance documents and expectations are fully
clarified, it is important to make assessments now to anticipate how to address
new requirements while there is still enough time to generate the information,
balancing how much is expected to be enough with the expense of doing too
much.
This program will be focusing on key
areas requiring significant effort to evaluate and update to maintain access to
the European marking such as understanding clinical data expectations,
generating clinical evaluation reports, updating technical documentation and
preparing for enhanced post-market requirements.
Learning Objectives:- Understand the impact of the new clinical requirements on clinical evidence
- Understand
new expectations of clinical evaluation reports
- Understand
the technical documentation required to demonstrate compliance
- Understand
enhanced post-market expectations
Who Should Attend:
- Medical
device regulatory affairs staff responsible for compliance, submissions,
clinical and post market of products intended for Europe
- Consultants
and suppliers supporting medical device regulatory affairs staff
Learning Levels: Basic, Intermediate
Speakers:
Sameer Jaiswal, PRP Consultant
Laurel Macomber, worldwide director of clinical evaluation, Johnson & Johnson Medical Device Companies
Mindy McCann, vice president of regulatory compliance,
Qserve Group
Keith Morel, vice president of regulatory compliance, Qserve
Group