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QUALITY TALK – October 2021

Arena Solutions
 
 
Device Classification Chart

How to Classify Your Medical Device for FDA Approval

#bestpractices #medicaldevice #compliance

Companies looking to market and sell medical devices in the United States must obtain approval from the U.S. Food and Drug Administration (FDA).

The first critical step to obtaining approval is classifying your medical device, as it determines the type of premarket submissions and applications that will be required for FDA review.

So where do you start, and how do you know that your device is assigned the proper classification?

In this article, you’ll learn:

  • FDA criteria for classifying Class I, II, and III devices
  • Differences between the medical device classes
  • Steps for assigning your medical device the right classification
Regulatory Management Software

How to Integrate Your Regulatory Stack with Arena for Outsized Results

#event #regulatorymanagement #medicaldevices

Integrating RIM systems directly with eQMS solutions can increase revenue, strengthen compliance, and improve collaboration within and outside your organization.

In this online event, Rimsys, the leading provider of RIM software, and our team of QMS experts discuss how you can integrate your regulatory stack with Arena to achieve outsized results.

View On-Demand Event

Product Innovation

Arena Fall 2021 Release Helps Manufacturers Drive Faster Product Innovation

#blog #qms #software #innovation

Arena’s recent Fall 2021 release was all about helping manufacturers improve product change visibility and drive faster product innovation.

Learn about the key Arena QMS enhancements, the product teams that are most impacted, and how the new QMS capabilities help increase productivity.

Learn More

Global Product

Meeting Global Product Development Needs Across Europe

#blog #cloudcomputing #saas #europe

Explore the different resources that have been put in place to help enhance the Arena QMS user experience across Europe:

  • Locally hosted QMS platform
  • Native speakers with industry-domain knowledge and best-practice expertise
  • Localisation of user interfaces, websites, educational resources, and other tools into several different languages

European Expansion

 

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