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Software as a Medical Device

RAC Credits
Tuesday, 28 July 2020 (9:00 AM) - Wednesday, 29 July 2020 (5:00 PM) Eastern Time (US & Canada)
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:  27 July 2020
Refund Deadline:  28 June 2020 
RAC Credits:  12 (Upon attending and completing the program)
Will the meeting be recorded?  Yes
Registration to 28 June 2020
RAPS Members: $800 
Nonmembers:  $900 
Registration from 29 June to 27 July 2020
RAPS Members: $900 
Nonmembers:  $1000
NOTE: Advance registration is required for this workshop therefore participants are encouraged to register early. 
Program Schedule 

28 July 2020 (9:00am–5:00pm EDT) 

·        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

29 July 2020 (9:00am-5:00pm EDT) 

·         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.
Pat Baird, senior regulatory specialist, Head of Global Software Systems, Philips
Lena Cordie, president, Qualitas Professional Services, LLC 
Michelle Jump, Medical Device Security, MedSec
Royth von Hahn, vice president of medical health services, TUVAM
Workshop Location

All cancellation requests must be submitted in writing via our online cancellation form. RAPS is unable to accept cancellations by phone. Please specify the name of the person registered and event title. Due to uncertainty surrounding the COVID-19 situation’s impact on travel our standard cancellation fees will be waived.  Should you need to cancel your registration, you can apply your credit to any RAPS program for the next 12 months. 

Substitutions may be accepted with written approval from RAPS and must be submitted to raps@raps.org.  Due to uncertainty surrounding the COVID-19 situation, RAPS will allow substitutions up to the first day of the event. 

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.

Proof of Attendance
RAPS will send an electronic letter or a certificate of attendance following the conclusion of the workshop.
Call RAPS Solutions Center at +1 301.770.2920, Ext 200
Registration Form 
If it is your preference, please use the Registration Form link below 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
Stephany Evans, Meeting & Events Specialist
+1 301 770 2920, Ext 229