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Staffing and Performance Benchmarks for Quality Function Highlight New Medical Device Study

CHAPEL HILL, N.C., May 4, 2012 /PRNewswire/ -- Medical device and medical technology companies devote significant resources to ensuring that their products meet quality standards and regulations at every stage of the product lifecycle, from R&D and product development to manufacturing and post-marketing activity. In the face of evolving regulatory standards and an increasingly competitive marketplace, medical device organizations are striving to improve their quality performance. 

To inform the device sector on an array of critical issues that revolve around the quality function, leading research and consulting firm Best Practices, LLC conducted a new research study on topics ranging from resource levels and complaint management to supplier management and inspection activities. The report, "Quality Staffing & Performance: Ensuring Quality & Safety While Managing Cost Effectiveness for Medical Device Companies," provides a blueprint for success that medical device quality leaders can use to evaluate their approach to critical quality activities. 

Key topics addressed in this study are:

  • What are the structure and roles of the Quality function at leading medical device companies
  • How are medical device companies mobilizing resources to meet quality standards and regulations throughout the product lifecycle
  • How do medical device companies approach both their IT solutions and training their employees
  • How are medical device companies managing important processes such as laboratory testing and outgoing inspections

The report includes insights and performance data from 11 quality executives from 11 leading medical device companies. All study participants contributed data through a field survey and representatives from several leading device organizations also provided additional insights through deep-dive interviews

The 143-page report delivers a wealth of insights around the quality function, including:

  • Meaningful metrics around Quality cost and staffing as well as organizational structure for the function in the U.S. and globally
  • Benchmarks regarding the standardization of quality management reviews, the volume of complaints processed by the function, and the auditing system of leading medical device companies
  • The number of corrections and removals companies handle each year and the dynamic between managing CAPAs and NCEs
  • The centralization and automation of document control and the document storage model and levels within the Quality function
  • Different approaches companies are taking to manage software quality staffing and reporting
  • The role of Quality in managing supplier quality and product testing

To access the full report or to download a complimentary summary, click on the following link:


Best Practices, LLC is a leading benchmarking, consulting and advisory services firm serving biopharmaceutical and medical device companies worldwide. Best Practices, LLC's clients include all the top 10 and 48 of the top 50 global healthcare companies. The firm conducts primary research and consulting using its comprehensive proprietary benchmarking tools and analysis. The operational insights, findings and analysis form the basis for our Benchmarking Reports, databases and advisory services to support executives in commercial and R&D operations.


SOURCE Best Practices, LLC
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