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Tips to Prepare for Your Next FDA Compliance Audit (Don't Forget CFR Title 21)

Medical device manufacturers are facing more FDA scrutiny of their quality systems than ever before. In the last decade, the quality systems elements with the most FDA observations have consistently been P&PC, CAPA and Design Controls. In 2017, P&PC and CAPA subsystems alone accounted for 34% and 33%, respectively, of the total 483 observations issued by the FDA, followed by Design Controls with 13%.

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How to Solve the Top 3 Medical Device Quality & Compliance Challenges

Most quality leaders don’t work in businesses with a quality first mindset. Surveys and research show that certain roadblocks are common for quality professionals across industries. Building awareness of the major challenges you’re likely to face and using a few clever strategies to handle them will help you dodge compliance risk and keep quality standards high.

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How to Harness the Power of Your Data with Tableau

A Beginners Guide to Tableau Blueprint

Imagine your organization gaining insights with intention and involvement, understanding information with business context, and making evidence-based decisions. Imagine using data to unleash the potential of your people.

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Tableau's 5 Best Practices to Enable Population Health

With the healthcare industry shifting from the fee-for-service model toward pay-for-performance value-based care, it is critical to begin understanding patients, the care they receive from your organization, and the social determinants they face at a deeper level than ever.

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How to Inspire Your Organization to Put Quality Systems First

by Federico Perez, Senior Quality and Compliance Manager

Today, most medical device manufacturers (and most organizations in general) don’t think of quality as an aspect of company culture. It is seen as one department’s responsibility. For some, the only time leadership really dives into questions of quality is when there’s a problem. Especially a problem that could impact market reputation or increase attention from regulatory bodies.

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The Latest Innovative Trends in Health Data Informatics

Changes in policy, the alignment of incentives, and heavier adoption of data sharing protocols have influenced provider implementation of electronic health records (EHR). With increased financial risk-sharing, more fixed budgets and a focus on value-based care, it is critical to use data to address the social determinants of health.

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How to Create a Data Driven Population Health Program

With the healthcare industry shifting from the fee-for-service model toward pay-for-performance value-based care, it is critical to begin understanding patients, the care they receive from your organization, and the social determinants they face at a deeper level than ever.

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How to Choose Data Sources for Your Population Health Program

With more and more data available to healthcare providers, it’s difficult to know where to begin sourcing data for your population health management program—especially in the early days of program creation. However, choosing the right data to start with is critical to getting the fastest results from your program and demonstrating its value to stakeholders. Here are the data sources we suggest getting started with.

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How Data Empowers Your Population Health Program to Improve Care and Reduce Costs

 

It’s no secret that technology and data have rapidly become a provider’s most powerful tools for reducing costs and improving care.

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Discover the Best Data Tools from Gartner Magic Quadrants

 

If you help make decisions about which vendors your business hires, then you should be familiar with Gartner’s Magic Quadrant. Magic Quadrants offer one-to-one vendor comparisons outlining strengths and cautions for each, as well as insights into overall market status. 

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