Navigating EU MDR Compliance
Medical device companies looking to sell in the European Economic Area (EEA) must comply with the EU #MDR. In this month's edition of the Arena Talk Newsletter, we discuss the key requirements and potential obstacles of EU MDR, as well as:
...and more.
The Impact of Post EU MDR Compliance on Medical Device Manufacturers
Are you looking to sell your medical devices in the EEA? With the EU MDR transition now in effect, you must submit a conformity assessment application and implement a quality management system (QMS) based on the latest EU MDR guidelines to obtain a product certification.
Here, we review the key requirements for maintaining product certifications under the EU MDR. We also explore some post-compliance hurdles facing manufacturers and highlight how Arena can help.
Make the Switch to Arena
Need to break free from legacy PLM and QMS platforms with infrequent and costly upgrades? It’s time to move to Arena, a modern, cloud-native solution. We’ve helped hundreds of companies transition from their outdated systems.
Watch this video to learn why more and more companies are making the switch!
Measure and Track Progress on Metrics That Matter
Using cloud-native PLM and QMS software, you can leverage your unique product and #quality data to monitor performance and identify potential blockers.
Arena Analytics eliminates the need to export, collate, and verify data, allowing you to focus on evaluating processes and making informed business decisions.
Advancing Development of Microsurgical Robotics With PLM
Previously, MMI - Medical Microinstruments, Inc. ’s product information was dispersed over multiple platforms and shared manually, which was not only time-consuming but also prone to error.
Since centralizing information in Arena’s unified PLM and QMS platform, MMI has accelerated product compliance and commercialization and established a solid foundation for growth.
Read on to learn more about MMI’s success with Arena.
领英推荐
A Deep Dive Into QMS Compliance for Medical Devices
In this DeviceTalks Tuesdays webinar, Arena Solution Architect Scott Segrin and Arena Customer Success Coach Gay Groce offer valuable insights on achieving and sustaining compliance with regulations such as FDA, ISO, and EU MDR.
You’ll learn best practices to refine regulatory compliance strategies and navigate various QMS requirements with confidence and efficiency.
Eight Sleep: The Tech Unlocking a Better Night’s Sleep
Eight Sleep is transforming the way we rest with its latest innovation, the Pod 4 Ultra. The AI-generated mattress can regulate your temperature, detect and prevent snoring, and adjust to alter your body position.
In this Third Angle podcast, Harry Xiao, Director of Hardware Programs at Eight Sleep, provides an insider’s look into the Pod 4 Ultra autopilot technology and explains the importance of rest in our day-to-day lives. Additionally, Jon Hirschtick , VP & Chief Evangelist at 美国参数技术公司 , reveals how Arena PLM helps Eight Sleep gain better control of their product information and stay connected with their global supply chain partners to bring quality products to market quickly.
Powering the Digital Factory Future
In this webinar, industry experts from First Resonance , Datum Source , and Arena by PTC explore the benefits and hurdles of adopting cutting-edge technologies across the #manufacturing value chain and how they fit together to facilitate data flow across systems and teams.
Topics covered:
Arena Tradeshows and Events
Medical Manufacturing Asia 2024
Visit us at Asia’s leading exhibition featuring the latest technologies, packaging, testing systems and services, as well as materials, substances, and components for the medical manufacturing industry.
PTC LiveWorx 2025
Save the date for PTC #LiveWorx 2025! Don’t miss PTC’s premier gathering of global creators, innovators, and disruptors in a format that delivers the highest quality education, entertainment, and inspiration.
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