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Artificial Intelligence: A Regulatory Perspective

RAC Credits
Virtual Programs
Wednesday, 03 November 2021 (10:00 AM) - Wednesday, 03 November 2021 (11:00 AM) Eastern Time (US & Canada)

Regulations struggle to keep up with rapidly evolving AI-driven solutions in the healthcare field. Characteristics and applications of AI are raising ethical and technological challenges that extend beyond current medical software regulatory framework.

Artificial Intelligence: A Regulatory Perspective will address questions such as:

  • What characteristics make AI so challenging?
  • How have commercialized solutions changed to address challenges with AI?
  • What are the implications of the EU MDR?
  • What can we expect from the future?

This live webcast will clarify the terminology and concepts under the umbrella term Artificial Intelligence and how it differs from standard software. Speakers will provide an overview of the regulatory framework on the EU market and analyze current regulatory requirements and limitations under the MDR using real examples of commercialized solutions. Finally, the program will explore the projection of AI and the challenges regulations will face in the near future.

Pricing Amounts & Deadlines


Learning Objectives:

Participants will:

  • understand the reasons behind the Artificial Intelligence regulatory challenge.
  • grasp basic strategies to commercialize AI driven medical device software in the EU market.
  • retain insight about what to expect from regulatory authorities in the near future.

Audience Learning Level

Basic: Content is introductory in nature and requires no requisite knowledge or experience to grasp concepts and related exercises. Basic educational activities are meant to establish a foundation of knowledge and/or competence that will be expanded upon in practice or in higher level activities.

Who Should Attend?

  • Regulatory consultants
  • QA and RA in the industry
  • Anyone interested in Artificial Intelligence and how its challenges are being addressed in the medical devices field


Irene Sanz supports medical device development projects for Novartis. She has been dedicated to the medical devices field for the past five years, working on research and development projects, and as a regulatory consultant for German and Swiss companies. Sanz holds an MSc in biomedical technologies, with a focus on artificial intelligence, from the University Carlos III of Madrid.

Ortzi Olasolo has dedicated most of his career to the design and development of medical devices, a field in which he possesses a strong technical and regulatory background. His current areas of interest are combination products and software as a medical device (SaMD). Olasolo holds an MSc in biomedical technologies from the University of Navarra.

Cancellation Policy

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 to RAPS is unable to accept cancellations by phone. 

Paid registration substitutions may be accepted with written approval from RAPS for requests received before the start of the event. To transfer a registration, email with the event title, name of the original registrant and the contact information for the new attendee. 

Proof of Attendance

RAPS will send an electronic letter or a certificate of attendance at the following the workshop.


Contact the RAPS Support Center:
Call +1 301 770 2920, ext. 200 (8:30 am–5:30 pm EST, Monday–Friday) or email