RAPS is closely monitoring developments in the Coronavirus (COVID-19) outbreak. See our public safety page for the latest updates.

Software as a Medical Device

12.0
RAC Credits
Wednesday, 15 April 2020 (9:00 AM) - Thursday, 16 April 2020 (5:00 PM) Eastern Time (US & Canada)

In order to provide you a level of certainty in planning in the face of the COVID-19 situation, this event is now being delivered online as a virtual event. We are working with our instructors to ensure that the same learning objectives and quality of the education will be delivered regardless of this modification. RAPS is closely monitoring developments in the Coronavirus (COVID-19) outbreak. See our public safety page for the latest updates.

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*

*Please see the cancellation policy below.  

RAC Credits: 12 (Upon attending and completing the program)

Registration to 16 March 2020
RAPS Members: $800
Nonmembers:  $900 

Registration from 17 March to 13 April 2020
RAPS Members: $900
Nonmembers:  $1,000

NOTE: Advance registration is required for this workshop therefore participants are encouraged to register early. Onsite registrations are not accepted. 

Program Schedule 

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.

Faculty
Pat Baird, senior regulatory specialist, Head of Global Software Standards, Philips

Lena Cordie, president, Qualitas Professional Services, LLC 

Michelle Jump, Medical Device Security, MedSec

Royth Von Hahn, vice president of medical health services, TUVAM

Cancellation 

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 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. 

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

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