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QUALITY TALK – February 2022

Arena Solutions

MDR & IVDR: Meeting New Post-Market Surveillance Requirements

#blog #compliance

Historically, the post-market surveillance (PMS) requirements for medical devices have been reactive, focusing primarily on the reporting of adverse events.

However, today there’s a shift toward more proactive planning and reporting with the release of the EU MDR and IVDR.

Review the essentials for PMS under the new European regulations and learn how a cloud-based quality management system (QMS) can help simplify the process.

Tip of the Month

QMS Tip: Streamlining Change Implementations

#tipsandtricks #qms

How do you implement product changes faster and with fewer errors?

In lieu of spreadsheets, calendars, and other manual systems, use a cloud-based QMS solution to manage and implement all the tasks that are tied to your change order.

You’ll have an audit-ready, automated system to notify and train impacted teams on their assigned tasks and an electronic record to easily track tasks as they are completed.

Learn More

Jump Start

7 Steps to Jump-start Your Digital Transformation

#blog #digitaltransformation

Today many manufacturers are undertaking a digital transformation to improve supply chain resilience, increase operational efficiency, and accelerate time to market.

However, realizing true success can be elusive especially when dealing with legacy systems, cybersecurity concerns, and other common barriers.

Learn the seven steps your organization can take to overcome these obstacles and get your digital program off to the right start.

Digital Jump-start    |    Toll-Free 866.937.1438

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