RAPS Vancouver Chapter: The Medical Device Single Audit Program (MDSAP): What Does it Mean for Device Manufacturers?

The RAPS Vancouver Chapter invites you to come engage with colleagues from your local regulatory communities for an interactive session on the Medical Device Single Audit Program (MDSAP). The MDSAP allows medical device manufacturers to be audited once for compliance to the regulatory requirements of up to five different medical device markets: Australia, Brazil, Canada, Japan and the United States. The program’s main mission is to “…jointly leverage regulatory resources to manage an efficient, effective, and sustainable single audit program focused on the oversight of medical device manufacturers.”

This presentation will discuss the current state and implementation of the MDSAP. As one of the first auditing organizations performing MDSAP audits, Intertek will share their experiences with the program and what it's implementation means for medical device manufacturers.

Topics to be covered include:

  • The current state of MDSAP (Upsides, Pitfalls and Observations)
  • Common concerns and misunderstandings about transition
  • The prospective future and where to find resources

This program is brought to you by the RAPS Vancouver Chapter and is intended to encourage knowledge sharing and community development among regulatory professionals. Dinner will be provided. RAC holders may claim two RAC recertification credits.




  • At a Glance
  • Agenda
  • Speaker
  • Registration Info
  • Cancellation

At a Glance

Date:

Wednesday, 18 October 2017 (5:30–8:00 pm PDT) 

Location:

LifeScan Canada
210-4321 Still Creek Drive
Burnaby, BC V5C 6S7

Directions are available online or by calling +1 604 293 2266

Registration Fees:

Prior to 11 October 2017
RAPS Members: $25          
List: $40 

On or after 11 October 2017
RAPS Members: $35         
List: $50 

Agenda

Wednesday, 18 October 2017

5:30–6:00 pm PDT     Registration Check-in, Networking and Dinner
6:00–8:00 pm PDT     Speaker Presentations and Q/A Session

Speaker

Alexander Crosby, medical program manager, Intertek's Business Assurance Americas Group

Registration Info

Prior to 11 October 2017
RAPS Members: $25          
List: $40 

On or after 11 October 2017
RAPS Members: $35         
List: $50 

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.

Photo Release: By registering for this program, you acknowledge that your picture may be taken by RAPS agents and consent to the use of your name and likeness by RAPS for any RAPS use as deemed appropriate by the organization.

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

Program Contact

Local contact: Jen Cabralda, RAC, RAPS Vancouver 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.