RAPS San Francisco Bay Area Chapter and ASQ NCDG - MDR and IVDR: Ready, Get Set, Go!


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On 5 April 2017, the European Parliament voted to adopt the new Medical Device Regulations (MDR) and In Vitro Diagnostic Regulations (IVDR), the final step before the regulations are formally published in the Official Journal of the European Union in May. The deadlines to comply with the new regulations are May 2020 for the MDR and May 2022 for the IVDR.

Join your quality and regulatory colleagues from ASQ Northern California Biomedical Discussion Group and the RAPS San Francisco Bay Area Chapter for an informative and interactive session on the biggest changes coming your way in the new MDR and IVDR. Recertification credits/units can be claimed: six RAC recertification credits and 0.6 ASQ RU credits.

Representatives from major Notified Bodies and leading quality/regulatory consulting firms will provide us with the practical tools and tips needed to effectively plan, prepare and transition from the MDD/IVDD to MDR/IVDR, as well as what to do if your Notified Body doesn’t make the cut.

View program agenda.




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

At a Glance

Date:

Friday, 9 June 2017 (7:30 am–4:45 pm PDT) 

Location:

Crowne Plaza San Jose-Silicon Valley
777 Bellew Drive
Milpitas, CA 95035

Directions are available online.

Educational Credits:

0.6 ASQ RU credits upon completion of the program

Registration Fees:

Prior to 12 May 2017
RAPS and ASQ Members: $175
List: $200

On or after 12 May 2017
RAPS and ASQ Members: $200
List: $225

Objectives

Topics to be covered during this workshop include:

  • MDR Requirements and the Impact on Key Stakeholders
  • Step-by-Step Transition Plan for Industry
  • Impact of New EU Regulations on Notified Bodies
  • MDR Certification Timelines
  • IVDR Certification Timelines
  • Tips to Prepare for a Successful Audit Under New EU Regulations
  • Overview of Notified Body Accreditation Process

Agenda

Friday, 9 June 2017

7:30–8:30 am Registration Check-In and Continental Breakfast
8:30 am Opening Comments and Introductions 
8:45 am–12:00 pm Morning Presentations and Panel Discussions 
12:00–1:00 pm Networking Luncheon 
1:00–4:30 pm Afternoon Presentations and Panel Discussions
4:30 pm Closing Remarks 
4:45 pm Program Adjourns


View full program agenda.

Speakers

Oliver Christ, CEO, PROSYSTEM AG
Connie Del Buono, founder, Synoptyx Inc., Auditor for DEKRA
Dan Griggs, MS, RAS, business development, BSI Group America
Nitin Mehta, TÜV SÜD America
Julien Senac, PhD, certification project manager, LNE/G-MED North America
Ibim Tariah, PhD, technical director, BSI Medical Device (BSI liaison with European Regulatory Authorities)

Registration Info

Prior to 12 May 2017
RAPS and ASQ Members: $175
List: $200

On or after 12 May 2017
RAPS and ASQ Members: $200
List: $225

>> Registration Online

ASQ Members: To receive member pricing, enter the appropriate market code during the online registration process. Contact ASQ NCDG leadership to receive the code.

>> 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

ASQ Contact: Dishita Purohit, ASQ Northern California Biomedical Discussion Group 

RAPS Contact: Cherry Mun, RAPS San Francisco Bay Area Chapter

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

 

 

 

Cancellation

All cancellation requests must be submitted to raps@raps.org by 1 June 2017. RAPS is unable to accept cancellations by phone. Please specify the name of the person registered and event title. A 20% cancellation fee will be assessed.

Substitutions may be accepted with written approval from RAPS, and must be submitted to raps@raps.org by 1 June 2017. 

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.

NOTE: RAPS reserves the right to request additional documentation in making determinations regarding cancellations and refunds. Refunds will be granted solely at the discretion of RAPS.