Navigating the expectations for software products is particularly challenging and requires a different approach from other medical devices. This workshop will review the current and evolving regulatory requirements globally including the EU and US for software as a medical device (SaMD). Issues to be addressed include how to determine when software is considered regulated as SaMD and how to determine correct class/classifications under global 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: 13 April 2020
Refund Deadline: 16 March 2020
RAC Credits: 12 (Upon attending and completing the program)
Will the meeting be recorded? No
Registration to 16 March 2020
RAPS Members: $1050
Registration from 17 March to 13 April 2020
RAPS Members: $1150
NOTE: Advance registration is required for this workshop therefore participants are encouraged to register early. Onsite registrations are not accepted.
15 April 2020 (9:00am–5:00pm)
- The Development of SaMD – Past, Present, Future: A Global Timeline of SaMD Guidance Documents and Regulations
- SaMD vs SiMD – Definition, Classification, and Variations
- The Cybersecurity, Privacy and Inter-Operability Issues with SaMD and Digital Health
- 21st Century Cures – The Regulatory Oversight Framework for SaMD and Digital Health
16 April 2020 (9:00am-5:00pm)
- FDA Pre-Certification Program
- How to Apply Various Standards & Guidance Documents
- Software Guidance Documents & Standards Across the Globe
- Creating a Strategy for Software as a Medical Device
- Global Regulatory Considerations for SaMD
- Clinical Decision Support Software
- Classification Use Case Studies
NOTE: The agenda may vary based on changing requirements.
Lena Cordie, president, Qualitas Professional Services, LLC
Michelle Jump, Medical Device Security, MedSec
Regulatory Affairs Professionals Society (RAPS) HQ
5635 Fishers Lane, Terrace Level
Rockville, MD 20852
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
All requests for cancellation must be received in writing or by calling customer service by 23 March 2020. 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 email@example.com. Substitutions may be accepted with written approval from RAPS by 1 April 2020.
Proof of Attendance
RAPS will send an electronic letter or a certificate of attendance upon request.
Call RAPS Solutions Center at +1 301.770.2920, Ext 200
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.
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.
+1 301 770 2920, Ext 291