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How Supply Chain Intelligence and Collaboration Enable Faster Response and Resilience

How Supply Chain Intelligence and Collaboration Enable Faster Response and Resilience

Supply chain intelligence and collaboration enable faster response and greater resilience by giving manufacturers real-time visibility into supplier risks, product data, and engineering changes. With connected information and structured collaboration, teams can identify issues earlier, evaluate alternative suppliers faster, reduce disruption, and maintain product quality while keeping product...

Customer Success Coach Gay Groce Shares Insights on Maximizing Your eQMS Investment

Customer Success Coach Gay Groce Shares Insights on Maximizing Your eQMS Investment

Transitioning to enterprise quality management system (eQMS) software may seem overwhelming for medical device companies at first, especially if they are coming from a paper-based system. We asked Arena’s Customer Success Coach Gay Groce to tell us about her background and share some insights on how companies can best utilize the Arena QMS platform for their product development processes and...

8 Key Elements of an Effective QMS

8 Key Elements of an Effective QMS

Compliance issues can create significant barriers for medical device companies looking to bring new products to market. In 2020 alone, the U.S. Food and Drug Administration (FDA) issued 422 citations or observations (i.e., Form 483) to medical device companies, indicating that their products were in potential violation of regulatory requirements1. These FDA observations typically stem from...