Arena Blog

ITAR and EAR Compliance and Modern Product Development (Part I)

As a high tech electronics manufacturer, you have your hands full developing and producing today’s complex products—a mix of sophisticated electrical, mechanical, and software elements. If you participate in the defense market, you may also be subject to strict federal regulations governing at least some of your product data and […]

Apr 22, 2019

Robotics and Spreadsheets: A Dangerous Combination

As it turns out, replacing humans is no simple task—just ask anyone in the robotics field. Robots designed to do relatively simple tasks like taking inventory in a supermarket are incredibly complex, involving thousands or tens of thousands of electrical and mechanical parts, as well as software components. In addition […]

Apr 10, 2019

Why Quality Teams Should Get Connected with Product Development

IntroductionQuality teams often think of their role as different and separate from product development. However, in today’s increasingly complex medical device market, a product-centric approach to quality management is fundamental to delivering high-quality devices.Next-level proactive quality management processes requires a closer connection between product development and quality teams to address […]

Mar 27, 2019

Cloud QMS Simplifies Validation

Why the need to validate?In the journey to deliver safe and effective devices to market, medical device manufacturers must simultaneously manage a myriad of regulations. To maintain quality compliance throughout the manufacturing process, quality leaders have the option to use various types of quality management systems (QMS). They can leverage […]

Mar 13, 2019

FDA Audits: The True Cost of Quality Problems

IntroductionFDA audits are an unavoidable and often unwelcome reality for medical device manufacturers, and knowing how to prepare for them effectively and confidently is vital to success. Not having a proper plan in place can have dire consequences for organizations. Quality failures can result in everything from warning letters to […]

Feb 27, 2019

What’s Killing Your Change Review Cycle Times?

Companies today face many challenges as they scale from early research and development stages to commercial production. Global competition, environmental compliance, and more distributed supply chains are just a few hurdles that must be overcome. The stakes are high if you fail to innovate and beat your competitors to market. […]

Feb 20, 2019