RAPS Wisconsin Chapter: The EU Medical Device Regulation (MDR): Ten Steps to Certification

Join regulatory colleagues from your region for an evening of networking and an expert presentation on the EU Medical Device Regulation.

Medical device manufacturers are facing major changes in the EU regulatory framework that oversees market access to Europe. This presentation will provide an overview of the draft MDR, including highlights of the Notified Bodies designation process, expected transition timelines and chapters and annexes of the regulation. You’ll come away with 10 key steps to successful certification.

This meeting is sponsored by the RAPS Wisconsin Chapter and is intended to promote knowledge advancement and facilitate networking among local regulatory and quality professionals. A light meal will be available. RAC holders can claim one RAC recertification credit.




  • At a Glance
  • Objectives & Audience
  • Agenda
  • Speaker
  • Registration Info
  • Cancellation

At a Glance

Date:

Wednesday, 26 April 2017 (5:30–8:00 pm CDT) 

Location:

GE Healthcare Research Park 
9900 West Innovation Drive
Wauwatosa, WI

Directions are available online

RAC Credits:

1 RAC certification credit upon completion of the program 

Registration Fees:

Prior to 19 April 2017:
RAPS members: $30
List: $45

On or after 19 April 2017:
RAPS members: $40     
List: $55

Objectives & Audience

At the conclusion of this program, you will have a better understanding of:

  • Changes to classification rules 
  • New conformity assessment routes 
  • Class II implantable devices 
  • The “scrutiny process” 
  • Clinical data/evaluation/evidence 
  • Summary of clinical and safety performance 
  • Postmarket surveillance  

Agenda

Wednesday, 26 April 2017

5:30–6:00 pm             Registration Check-in

6:30-7:00 pm             Networking and Dinner

7:00–8:00 pm             Speaker Presentations and Q/A Session 

Speaker

Ibim Tariah, PhD, technical director, BSI Healthcare 

Registration Info

Prior to 19 April 2017:
RAPS members: $30
List: $45

On or after 19 April 2017:
RAPS members: $40     
List: $55
 
>> Registration Online

>> Registration Form (PDF) – for registration by mail or fax.

Other Information

RAPS reserves the right to cancel this program at its sole discretion. RAPS will not be responsible for travel or other costs incurred due to cancellation.

Questions? Contact RAPS Solutions Center at +1 301 770 2920, ext. 200, or email raps@raps.org to learn about the special student registration rate. 

Program Contacts

Local Contact:  Adrienne Lenz, RAC, RAPS Wisconsin Chapter 
RAPS Contact: Wesley Carr, senior program manager, chapter and volunteer relations, RAPS    

Cancellation

Registration fees for this event are nonrefundable. Substitutions may be accepted with written approval from RAPS. If you have questions or concerns, please contact RAPS customer service at +1 301 770 2920, ext. 200, or via email at raps@raps.org.