Join us for an insightful and comprehensive event focused on the critical role of standards in the medical device industry. This event will feature expert speakers from various organizations, including FDA, Health Canada, Dekra and QServe, who will share their knowledge and experiences on the standardization process and its impact on regulatory requirements. Following the main event, attendees are invited to a networking session at the same venue. Refreshments and catering will be available to facilitate a comfortable and engaging environment for all participants.
Don’t miss this opportunity to enhance your understanding of standards and their application in the medical device industry. Register now to secure your spot!
Registration Fees & Deadlines
Member $50 | Nonmember $65
Agenda
- 12:45-1:00pm: Registration
- 1:00-1:10pm: Welcome and Introductions
- 1:10-1:30pm: Background on the standardization process. Presented by QServe.
- 1:30-2:15pm: Learn how to leverage FDA-recognized standards to streamline device review and the latest on the Accreditation Scheme for Conformity Assessment (ASCA). Presented by FDA. (Virtual)
- 2:15-3:00pm: Learn how to leverage standards in Canada as a basis for international alignment on regulatory requirements. Presented by Health Canada. (Virtual)
- 3:00-3:15pm: Break
- 3:15-4:00pm: Learn about expectations on the assessment of new and revised standards, timelines for implementation, and best practices for GSPR checklists and maintenance of technical documentation. Presented by DEKRA.
- 4:00-5:00pm: Gain an understanding on the practical use of standards in design control for US, EU, and HC device submissions. Presented by QServe.
- 5:00-5:30pm: Interactive Q&A session to clarify any doubts and gain deeper insights.
- 5:45-7:30pm: Engage with fellow attendees and speakers in person following the event.
Speakers
Jennifer M. Coble, MPM
Regulatory Policy Analyst, Conformity Assessment Program (CAP), FDA
Kevin Day, P.Eng, SM
Manager, Cardiovascular Division | Medical Devices Directorate, Health Canada
Keith Morel, PhD
VP Regulatory Compliance | Principle Consultant, Qserve Group US
Sponsor
Alcon
Donating space for this event
Accommodations & Travel Information
Alcon Johns Creek – Commons Building (look for ‘Contact Café’ sign)
11460 Johns Creek Pkwy
Johns Creek, GA 30097
Campus Map
Directions and Parking: Alcon Johns Creek encompasses several buildings and parking lots. To ensure you arrive at the correct location, please use the street address: 11460 Johns Creek Pkwy, Duluth, GA 30097. Building and check in information: The event will be hosted in the Johns Creek Commons building. Look for the exterior sign marked "Contact Cafe" to identify the correct building. A visual map is provided as an attachment for your convenience, detailing the building's location within the campus. Please locate the RAPS table adjacent to the building's entrance to check in upon your arrival.
Platinum Chapter Sponsors
Cancellations and Refunds
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. All cancellation requests must be submitted in writing to support@raps.org. Cancellations will receive a full refund minus a 20% administrative fee. RAPS is unable to accept cancellations by phone.
Substitutions
Paid registration substitutions may be accepted with written approval from RAPS for requests received before the start of the event. To transfer a registration, email support@raps.org with the event title, name of the original registrant and the contact information for the new attendee.
Proof of Attendance
A certificate of attendance can be downloaded from the RAPS Learning Portal following the event.
Questions
Contact the RAPS Support Center:
Call +1 301 770 2920, ext. 200 (8:30 am–5:30 pm EST, Monday–Friday) or email
RAPS@raps.org