As Latin America cements its role as a global hub for medical device manufacturing and exports, staying ahead of evolving quality, regulatory, and risk expectations has never been more critical. Whether you’re in Mexico’s dynamic border clusters, Costa Rica’s thriving OEM ecosystem, or Argentina’s expanding manufacturing landscape, your teams face mounting demands– from ISO 13485 certifications to FDA audits to global supply chain pressures.
And yet, high-level technical training in Spanish remains surprisingly scarce across the region.
That’s why ELIQUENT Life Sciences (formerly Oriel STAT A MATRIX) is excited to roll out a robust lineup of 9 Spanish-language public seminars, all delivered virtually, specifically crafted for medical device professionals across Latin America. Whether you’re managing compliance from Monterrey, overseeing validations in Alajuela, or supporting global RA/QA from Santo Domingo, these courses are designed to give you the tools, confidence, and credentials to excel.
1 Source: https://www.marketdataforecast.com/market-reports/latin-america-medical-devices-market
In short? Mastering these frameworks isn’t just about compliance – it’s about staying competitive, safeguarding certifications, and winning new business.
All nine courses below are delivered as virtual instructor-led training (VILT) in Spanish, featuring:
ISO 13485 Lead Auditor Training Course
Sep 1-11, 2025
Master how to plan, conduct, and follow up on audits to ISO 13485:2016 using ISO 19011:2018 guidelines. This course, which is taught over 9 half-days, is ideal for internal auditors and supplier QA leads looking to achieve recognized credentials.
Medical Device CAPA and Root Cause Investigation
Oct 13-17, 2025
This course runs over 5 half-days and is dedicated to building robust CAPA programs. Learn risk-based CAPA strategies, craft effective problem statements, and apply tools like fishbone and 5 Whys to determine true root causes.
QMS Training for Medical Devices: ISO 13485:2016 and FDA QMSR
Oct 27-31, 2025
Understand how to align your QMS with ISO 13485:2016 and the new FDA Quality Management System Regulation (QMSR). This course includes practical comparisons, case studies, and readiness tips for audits.
Process Validation for Medical Devices: FDA and ISO 13485 Requirements
Nov 10-14, 2025
Get an in-depth look at the validation cycle, from IQ/OQ/PQ protocols to risk-based approaches and key statistical methods. Perfect for quality, regulatory, and engineering professionals.
ISO 14971 Medical Device Risk Management and Analysis
Nov 24-28, 2025
This course offers an intensive examination of ISO 14971:2019 over 5 half-days. Take a deep dive into integrating risk management across your device’s life cycle, from design to postmarket. Learn to select and apply the right tools, and stay audit-ready.
ISO 13485 Overview for Medical Device and IVD Manufacturers
Dec 9, 2025
Gain a solid grounding in the ISO 13485:2016 standard, from quality planning to production controls, all in a concise format.
Transition from FDA QSR to QMSR
Dec 10, 2025
Get crystal clear on the key differences between FDA’s old QSR and the new QMSR requirements in this class. This information is essential for quality and regulatory leaders prepping for the regulatory switch.
Medical Device Single Audit Program (MDSAP) Essentials
Dec 11, 2025
Demystify MDSAP: Learn how audits are structured, what regulators expect, and how to leverage the nonconformity grading matrix. This course offers a smart primer for anyone in multi-market compliance.
ISO 14971 Risk Management – Risk Analysis Deep Dive
Dec 12, 2025
Focuses on practical application of ISO 14971:2019 risk analysis — hazards, severity, probability, and residual risk. Great for design, QA, and RA teams.
Whether you’re based in Latin America or leading global operations with teams in the region, there’s never been a better moment to invest in your people. Seats are limited, and these Spanish-language courses don’t come around often.
Secure your spot today and stay ahead of global regulatory and quality expectations. Your competitive edge starts with world-class compliance.
Leverage ELIQUENT’s expertise to build a world-class life sciences workforce in Latin America. Reach out to us today for expert training and consulting support, available in both English and Spanish.
Contact Silvia Vásquez at svasquez@eliquent.com or get answers right now by calling +506.8812.6203. Be sure to ask Silvia about group discount pricing.
US OfficeWashington DC
EU OfficeCork, Ireland
UNITED STATES
1055 Thomas Jefferson St. NW
Suite 304
Washington, DC 20007
Phone: 1.800.472.6477
EUROPE
4 Emmet House, Barrack Square
Ballincollig
Cork, Ireland
Phone: +353 21 212 8530