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.
Medical Device Supply Chain Struggles? Download our FREE guide and discover how strategic supplier management builds resilience for a reliable flow of critical devices. We delve into the industry’s unique challenges – strict regulations, quality needs, and constant innovation.
Discover what to consider when designing and manufacturing point-of-care diagnostic devices, including ensuring measurement accuracy and reliability, user-friendly operation, and scalable production with validated manufacturing processes.
