The current state of large language models makes them a useful accessory to human regulatory professionals, but can they replace experts on regulatory tasks? Read the study to find out.
Discover strategies for managing non-conformance in life sciences while adapting to evolving regulations. See how to integrate your quality system, risk management, and automation to more efficiently and effectively maintain compliance with global regulatory bodies.
Symmetry Surgical standardized quality processes and improved supplier collaboration to drive efficiency, visibility, and faster corrective actions. Learn how their centralized data and analytics enable faster decisions, stronger supplier collaboration, and measurable efficiency gains.
A series of interviews with industry leaders and innovators. This episode features Rene Zoelfl of PTC. Rene is the Global MedTech Advisor for PTC’s MedTech Practice. Here, he shares his thoughts in a discussion around the Digital Thread…what it is and why the concept is vital for MedTech product teams to embrace as medical device product management accelerates to a future pace where data and access to it is the difference between success and failure.
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.