Aligning Quality Resources, Activities and Performance Measures to Efficiently Deliver New Medical Device Products
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SOURCE Best Practices, LLC
CHAPEL HILL, N.C., Dec. 13, 2013 /PRNewswire/ -- In the medical device sector, the Quality function remains a critical component of success at every stage of a product's lifecycle, from development to post-market.
While its importance has remained constant through the decades, the role of Quality has expanded in the face of an evolving regulatory environment and an increasingly competitive marketplace. In this challenging setting, medical device organizations must constantly evaluate their Quality groups to assure their resources, activities and performance measures are aligned to efficiently deliver new products that meet quality standards and regulations.
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 more than 700 metrics and 25 narratives around the quality function. This study provides valuable insights and benchmarks, 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
ABOUT BEST PRACTICES, LLC 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.
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