Software as a Medical Device

12.0
RAC Credits
Tuesday, 19 November 2019 (9:00 AM) - Wednesday, 20 November 2019 (5:00 PM) (Eastern Time (US & Canada))
5635 Fishers Ln
Rockville, Maryland, USA, 20852-1796

Navigating the expectations for software products is particularly challenging and requires a different approach from other medical devices. On 27 September 2019, the FDA issued a new draft guidance, Clinical Decision Support Software, which replaces the 2017 draft guidance, Clinical and Patient Decision Support Software. Much of the text of the new guidance is new or revised compared to the prior draft, including an expanded discussion of the FDA's interpretation of criterion (1) of the Cures Act and the application of IMDRF framework. Attend this in-person workshop and stay up-to-date on the evolving regulatory requirements for software as a medical device (SaMD) both in the EU and US.

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, and 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, Medtronic 

Linda Ricci, health scientist, center for devices and radiological health, US FDA  

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

Register