Entries with Keyword arena-blog
What’s Killing Your Change Review Cycle Tim ...
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. […]
How Medical Device Manufacturers Can Avoid Re ...
Introduction 2018 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 […]
Arena Analytics Provides Key Insights Into Pr ...
Arena introduced Arena Analytics, a robust business intelligence (BI) solution, that enables companies to gain meaningful insights into how their product-related processes are performing. Arena Analytics is powered by GoodData, a leading provider of Insights-as-a-Service, and creates highly visual dashboards that integrate the power of BI with product lifecycle management […]
Keys for CAPA Success
Establishing 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 […]
Navigating the 510(k) Clearance and PMA Appro ...
Introduction There 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 […]
Three Quality Subsystem Improvements That Str ...
Introduction Maintaining 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 […]
Eliminate Barriers to Innovation Part IV
Connecting Products and Projects Helps Streamline Regulatory Compliance This is the fourth and final part of our series on how to break down the barriers to product innovation. We have demonstrated how to connect disparate product teams with a single source of truth to simplify collaboration, streamline new development, and […]