A four-decade journey took a bold new turn in 2019 when Lumitex strategically expanded into Mexico, with the help of Entrada Group, to lay the groundwork for a true global footprint.
This story analyzes Eastek’s journey and explore how this ambition wasn’t born from a desire to simply grow bigger—it was driven by a vision to serve clients more effectively in the Americas, Europe and Asia, protect their intellectual property (IP), and scale in ways that allowed them to compete with the largest electronics manufacturers in the industry.
The 2025 Medtech Regulatory Affairs Benchmark reveals that many medtech companies lack confidence in their data’s completeness or accuracy and still rely heavily on manual processes to maintain compliance. This is largely underpinned by pervasive siloed processes, which make preparing regulatory submissions a resource-intensive endeavor.
Are you ensuring your medtech products meet customer and regulatory requirements. ISO 13485 is the regulatory standard for MedTech Quality Management Systems. It emphasizes the importance for medical device manufacturers to develop high-quality products. Get your guide for building a comprehensive and compliant ISO 13485 Quality Management System.
New product development processes that are overly siloed are stifling MedTech innovation. Here’s why and the steps you can take to get engineering, clinical, regulatory, marketing, and manufacturing all working in parallel from day one.
Whether you’re managing complex product portfolios, navigating regulatory pressures, or striving to deliver higher customer satisfaction, this guide will help you understand the tangible benefits of integrating ALM and PLM.
MedTech leaders face intense pressure to innovate rapidly while maintaining strict regulatory compliance, controlling costs, and improving patient outcomes. The global MedTech market is poised for significant growth. Yet, this opportunity comes with growing complexity. To succeed, MedTech organizations must move beyond fragmented systems and manual processes. View this guide to preparing for a more agile, resilient, and compliant future
An April 2024 survey of medical device regulatory professionals illustrates potential regulatory fatigue. See how resource constraints, ever changing global policy, and an underutilization of technology/digital process are impacting internal burden and fatigue and where implementing new regulatory strategies, upgrading organizational expertise, adding outsourced regulatory services are helping teams cope.
If you’re considering a RIM system, it’s critical to determine the right scope, software capabilities, and balance between cost and value. Learn how to evaluate each piece with this RIM buyer’s guide for medtech.
Explore our EU MDR Checklist designed to help you navigate EU MDR compliance. This practical tool guides you through essential steps to adapt your processes and ensure documentation meets regulatory standards. Start your compliance journey with confidence.