Arena Blog

Scott Reedy

Scott Reedy

Scott Reedy is the Senior Director of Marketing for Arena Solutions. He has held strategic roles with enterprise software companies in consulting, sales, and marketing over the past 20 years. Scott has experience selling and implementing cloud-based solutions and spent a decade managing new product development and introduction processes for a global manufacturing company.

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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 potential quality issues and develop compliant processes. This connection improves collaboration, while fostering a smooth and innovative product ...

March 25, 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 manual, paper-based ones; on-premises software; or cloud-based QMS software. The FDA doesn’t regulate what type of system manufacturers ...

March 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 major compliance actions requiring facility shutdowns, and, since medical device recalls have been on the rise, the threat of regulatory ...

Feb. 28, 2019

Five Questions Every Medical Device Manufacturer Should Ask About QMS Solutions

IntroductionTo help ensure that medical devices are safe for use and will function as intended, the FDA requires that manufacturers of these products establish and follow quality systems in accordance with current good manufacturing practices (CGMP). While the quality system regulation (QSR) does not prescribe how a manufacturer must produce a specific device, it does state that manufacturers “should use good judgment when developing their quality system and apply those ...

Feb. 11, 2019

How Medical Device Manufacturers Can Avoid Major Device Recall Factors

Introduction2018 was a difficult year for many medical device manufacturers, with large spikes in Class I recalls and a whopping 186,580,917 devices across 343 recalls affected in Q1. While the impact in Q2 and Q3 was lower, the number of recalls was still high. In fact, Q2 had the most single-quarter recalls since 2005, clocking in at 360 recalls affecting 42.4 million devices.So, what gives? Why ...

Jan. 31, 2019