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When Do You Need a Quality Management System?

Arena Solutions

And, if you are a medical device company, one of these projects will be a quality management system (QMS) solution to meet the compliance requirements of FDA, EU MDR, and ISO at scale. These are all important considerations you need to address ONCE you decide it is time for any system, including QMS. What does this mean?

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From Requirements to Launch: Arena’s Expanded QMS Capabilities Help Speed Innovation

Arena Solutions

Getting high-quality, compliant products to market is a long and arduous journey for most manufacturers. We also reveal how Arena’s expanded quality management capabilities help organizations overcome these setbacks to introduce products faster. 510(k) , premarket approval , CE certification ) can take up to one year.

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Purpose-Built Platforms Perform Better

Arena Solutions

Most importantly, when you look for an enterprise PLM solution, take a close look at the platform. Don’t risk your company’s success on repurposed CAD, ERP, or CRM platforms. That’s why purpose-built platforms are ideal for companies that need an end-to-end solution designed specifically to support the PLM needs of the business.

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Quality and Regulatory Alignment for Audit Readiness

Arena Solutions

Quality and Regulatory Alignment for Audit Readiness Full transcript below: Wendy Levine Welcome to today’s webinar, exploring “Quality and Regulatory Alignment for Audit Readiness.” So, Arena is a cloud-native system that controls product lifecycle as well as your quality processes.

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Helping Companies Identify Environmental Sustainability Opportunities

Arena Solutions

The company offers a software-as-a-service (SaaS) lifecycle assessment (LCA) platform that enables businesses to measure and understand the carbon footprint of their products, identify areas for reduction, and use results to better drive sustainability across their supply chains.

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What Are the Key Elements of a Quality Management System (QMS)?

Arena Solutions

In today’s highly competitive landscape, life sciences companies are tasked with getting quality products to market faster while meeting customer expectations and regulatory requirements. What Is a Quality Management System (QMS)? What Is the Purpose of a QMS? Meeting ISO 9001, FDA, EU MDR, and Other QMS Standards.

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Rethinking Your Digital Transformation Strategy

QAD

After early packet switching networks such as ARPANET and the NPL network evolved into what we know today as the World Wide Web, digital channels known as websites became prime platforms for data-sharing, online discussion forums, blogs, social networking and online shopping. Enterprise Quality Management System (QMS).