This workshop will review the current and evolving regulatory requirements both in the EU and US for software as a medical device (SaMD). Navigating the expectations for software products is particularly challenging and requires a different approach from other medical devices. Issues to be addressed include how to determine when software is considered regulated as SaMD and how to determine correct class/classifications under US and EU requirements. Performing risk management/assessments for software is generally more challenging, so the session will include practical case studies to work through completing the required evaluations. This workshop will be particularly beneficial to regulatory professionals, QA professionals and application developers who are responsible for managing and planning regulatory compliance for software products.
Registration Closes: 15 November 2019
Refund Deadline: 13 November 2019
RAC Credits: 12 (Upon attending and completing the program)
Will the meeting be recorded? No
Registration from 15 October to 15 November 2019
RAPS Members: $1050
Nonmembers: $1150
NOTE: Advance registration is required for this workshop therefore participants are encouraged to register early. Onsite registrations are not accepted.
Program Schedule
Tuesday, 19 November (9:00am–5:00pm) (TBD)
Wednesday, 20 November (9:00am-5:00pm) (TBD)
NOTE: The agenda may vary based on changing requirements.
Faculty
Lena Cordie, president, Qualitas Professional Services, LLC
Michelle Jump, vice president of cyber program initiatives, NovaLeah
Patty Krantz-Zuppan, distinguished engineer and technical fellow, Metronic
All requests for cancellation must be received in writing or by calling customer service by 13 November. Supporting documentation is required and must be received by the deadline specified. All refunds are subject to a 20% assessment unless otherwise specified.
Workshop Location
Regulatory Affairs Professionals Society (RAPS) HQ
5635 Fishers Lane, Terrace Level
Rockville, MD 20852
Accommodation Options
Below is a list of nearby hotel properties near host venue.
Even Hotel Rockville (Walking Distance)
1775 Rockville Pike
Rockville, MD 20852
Reservations: +1 877 834 3613
Hilton Washington DC/Rockville Hotel (Walking Distance)
1750 Rockville Pike
Rockville, MD 20852
Reservations: +1 301 468 1100
Bethesda North Marriott Hotel
701 Marinelli Road
Bethesda, MD 20852
Reservations: +1 301 822 9200
Bethesda Marriott Suites
6711 Democracy Boulevard
Bethesda, MD 20817
Reservations: +1 800 228 9290
Cancellation
All requests for cancellation must be received in writing or by calling customer service by 13 November. Supporting documentation is required and must be received by the deadline specified. All refunds are subject to a 20% assessment unless otherwise specified.
Please send your cancellation information, with documentation, specifying the name of the person registered, customer (or member) number and event title via email to raps@raps.org. Substitutions may be accepted with written approval from RAPS by 5 November.
Proof of Attendance
RAPS will send an electronic letter or a certificate of attendance upon request.
Questions
Call RAPS Solutions Center at +1 301.770.2920, Ext 200
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.
Registration Form
If it is your preference, please use the Registration Form to register by mail, email or fax. To expedite your registration for mail orders, your employer must include a copy of the completed registration form. A RAPS online account will be created to complete your purchase if you are not a member or past customer.
Program Contact
Nichelle Sankey
nsankey@raps.org
+1 301 770 2920, Ext 291