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Mar 14, 2022 10:00 AM - Mar 16, 2022 3:15 PM

(US Eastern Standard Time)

Latin America Regulatory Conference

DIA Your Way! Join us virtually from the comfort of your home/office March 14-16 or watch later at a time that works for you. This event provides access to the materials for a full two months!

Session 5: Rethinking MedTech and Regulatory Transparency for Medical Devices in the LATAM Region

Session Chair(s)

Viktoria  Magyar, LLM, MSc

Viktoria Magyar, LLM, MSc

Doctoral Student, Department of Regulatory and Quality Sciences

USC Alfred E. Mann School of Pharmacy and Pharmaceutical Sciences, United States

Roberta  Mele Mazza, RPh, RAC

Roberta Mele Mazza, RPh, RAC

Q&RA Manager, División Diagnóstica

Productos Roche , Argentina

The COVID-19 pandemic has put the medical technology (MedTech) industry at center stage with unprecedented demand for diagnostic test kits and other medical equipment, in addition to extraordinary measures underway to accelerate their manufacturing capabilities. Regulatory flexibility, risk-based approach, remote technologies such as, cloud-based monitoring software, telehealth, and virtual site visits, serve the purpose of optimization of clinical outcomes and patient satisfaction. This session will focus on regulatory challenges of the MedTech industry during and following the pandemic, debate ideas to rethinking the public-health response from a regulator and industry perspective, emphasize the growing relevance of AI/ML-enabled medical devices, and highlight pandemic accelerated digital transformation trends.

Learning Objective :
  • Recognize the regulatory challenges of medical device registration pre before and during the pandemic
  • State the impact medical technology innovation has on public health
  • Define the meaning of transparency to different stakeholders of AI and ML-enabled medical devices
  • List the key affected areas within industry operations by the COVID-19 pandemic
  • Describe important areas for future development within the medical device industry


Nathan Allen Carrington, PhD

What are the Current and Possible Means of Promoting Transparency of AI/ML-Enabled Medical Devices to Users? What are Important Areas for Future Development?

Nathan Allen Carrington, PhD

Roche Diagnostics, United States

Head of Digital Health and Innovation, Global Regulatory Policy and Intelligence

Ismary Alfonso  Orta, MD, PhD


Ismary Alfonso Orta, MD, PhD

CECMED, Cayman Islands

Head of Surveillance of Medical Products

Brandon D Gallas, PhD

Regulatory Mechanisms for Software as a Medical Device and the Use of Digital Pathology During the Pandemic

Brandon D Gallas, PhD


Research Mathematical Statician

Vesa  Vuniqi, MS

Regulating During the Pandemic –The Role of FDA’s Latin America Office

Vesa Vuniqi, MS

FDA, United States

International Relations Specialist, Latin America Office

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