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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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

Keys for CAPA Success

IntroductionEstablishing Current Good Manufacturing Practices (CGMPs) ensures that medical device manufacturers can better comply with regulations and standards like FDA 21 CFR part 820.100 and ISO 13485, including quality systems that identify, analyze, and correct quality issues. These corrective and preventive action (CAPA) processes are a major component of delivering and supporting medical devices in today’s highly regulated marketplace. While CAPA-related regulations do not specify every detail required ...

Jan. 22, 2019

The FDA’s Adoption of ISO 13485: What Medical Device Manufacturers Should Know

IntroductionAs globalization of medical device supply chains has continued to increase, regulatory bodies have grappled with how to bridge the gap between domestic and foreign regulation. Without a unified approach to both, the daily practice of ensuring that regulatory processes are followed and properly documented is even more challenging. The announcement that the FDA plans to use ISO 13485 as the basis for its quality system legislation signals an important ...

Dec. 19, 2018

Three Quality Subsystem Improvements That Streamline FDA Compliance

IntroductionMaintaining readiness for FDA inspections can be arduous and time-consuming, and the need for preparedness is growing. While the FDA continues to issue more observations than Form 483s, the number of observations has been decreasing, while the count of Form 483s has been increasing. A renewed focus on the quality subsystems that are most frequently cited with issues in Form 483 inspections can streamline FDA compliance and inspection readiness. Here ...

Dec. 10, 2018