Arena Blog

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

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 […]

Jan 22, 2019

Navigating the 510(k) Clearance and PMA Approval Process

IntroductionThere are two main paths that medical device manufacturers can use to bring moderate- and high-risk devices to market with the FDA’s permission: through submittal of a premarket approval (PMA) request or 510(k) application.Submitting a PMA application is a more extensive approach, requiring substantial evidence that provides “reasonable assurance that […]

Jan 9, 2019

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 […]

Dec 12, 2018