RAPS Twin Cities Chapter: An Update on Global Regulations

Come join colleagues from your local regulatory community for an evening of networking and to hear two presentations on global regulations. This event is coordinated by the RAPS Twin Cities Chapter and is intended to encourage knowledge sharing and community development. Dinner will be provided. RAC holders may claim two RAC recertification credits.

Presentation One: Updates on EU Regulations
This session will focus on the new EU regulatory expectations for medical devices and IVDs as introduced by the new Medical Device Regulation and In Vitro Diagnostics Regulation. Topics covered will include:

  • What are the critical changes within the new regulations?
  • What are the timelines for compliance?
  • What will be the impact on interactions with Notified Bodies?
  • What are the key steps to achieving compliance?

Part 2: Updates on the US 510(k) Process
This session will focus on recent experience with the new 510(k) substantial equivalence guidance and flowchart as well a practical discussion of what is going on today in 510(k) reviews. Topics covered will include:

  • What factors initiate wanting a pre-IDE meeting?
  • How can 501(k) criteria be strategically presented?
  • What will it take to be successful in getting clearance today?
  • What factors will affect the overall FDA review?
    • Working with FDA review teams today
    • Guidance documents
    • Specialists
    • Dynamics of team review
    • Outside groups (industry and medical)
    • Scientific minutiae vs what’s truly important

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




  • At a Glance
  • Objectives
  • Agenda
  • Speakers
  • Registration Info
  • Cancellation

At a Glance

Date:

Thursday, 11 May 2017  (5:30–8:30 pm CDT) 

Location:

Saint Cloud State University at Plymouth
9750 Rockford Road
Plymouth, MN 55442

Directions are available online or by calling +1 320 308 6000.

RAC Credits:

2 RAC certification credits upon completion of the program 

Registration Fees:

Prior to 4 May 2017:
RAPS Members: $30
List: $45

On or after 4 May 2017:
RAPS Members: $40
List: $55

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

Objectives

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

  • The critical changes within the new regulations
  • The timelines for compliance
  • The impact on interactions with Notified Bodies
  • What factors initiate wanting a pre-IDE meeting
  • How can 501(k) criteria be strategically presented
  • What factors will affect the overall FDA review
  • What it will take to be successful in getting clearance today

Agenda

Thursday, 11 May 2017 (5:30–8:30 pm CDT)

5:30–6:15 pm     Registration Check-in, Networking and Dinner
6:15–6:45 pm     Activity and Chapter Business
6:45–8:30 pm     Speaking Presentation and Q/A Session

Speakers

Mark DuVal, JD, FRAPS, CEO & president, DuVal & Associates
Lisa Pritchard, regulatory, quality and compliance consultant, Duval & Associates
Beth Luoma, JD, associate attorney, Duval & Associates
Jeff Zumhofe, quality systems consultant, Duval & Associates

Registration Info

Prior to 4 May 2017:
RAPS Members: $30
List: $45

On or after 4 May 2017:
RAPS Members: $40
List: $55

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

>> 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? Call RAPS Solutions Center at +1 301 770 2920, ext. 200, or email raps@raps.org.

Program Contact

Local Contact: Lean Cordie, chair, RAPS Twin Cities Chapter 

RAPS Contact: Wesley Carr, senior program manager, chapter and volunteer relations 

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.