Navigating EU MDR Compliance
Sharing monthly #product and #quality insights to help bring products to life.

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:

  • Why companies should move from legacy #PLM and #QMS
  • How #cloudnative PLM and QMS help monitor key product and quality data
  • What are some #bestpractices for QMS #compliance

...and more.

The Impact of Post EU MDR Compliance on Medical Device Manufacturers

Two engineers using QMS
Learn the key requirements of the EU MDR and how Arena can help with post-compliance hurdles.

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.

Read the Blog

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 We’ve helped hundreds of companies transition from their outdated systems.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

Arena Talk Tip of the Month
Arena Talk Tip of the Month

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.

Learn More

Advancing Development of Microsurgical Robotics With PLM

MMI advances development of micosurgical robots with PLM
Read how MMI streamlined product compliance and commercialization with Arena.

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.

Read the Story

A Deep Dive Into QMS Compliance for Medical Devices

Navigating Regulatory Compliance
Hear best practices for regulatory compliance strategies from Arena's QMS experts.

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.

Watch the On-demand Webinar

Eight Sleep: The Tech Unlocking a Better Night’s Sleep

Eight Sleep unlocks better sleep with Arena PLM
Listen to the podcast to learn how Arena PLM helps Eight Sleep collaborate with global partners.

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.

Listen to the Podcast

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:

  • Overview of different platforms used in manufacturing
  • Checklist for evaluating the interoperability of your technology ecosystem
  • Demystifying open #APIs and their role in enabling seamless connectivity across the factory floor
  • Essential components of the ultimate factory tech stack
  • Managing security for cloud-native and interconnected tools

Arena Tradeshows and Events

Medical Manufacturing Asia 2024

  • September 11-13, 2024
  • Singapore
  • Booth 2T08

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.

Join Us

PTC LiveWorx 2025

  • May 19-22, 2025
  • Boston, Massachusetts

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.

Join Us

Want to keep up with the latest?PLM and QMS?insights from Arena? Subscribe to our blog here .

要查看或添加评论,请登录

社区洞察

其他会员也浏览了