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.
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 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.
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
To access the full report or to download a complimentary summary containing insights found in this report, click on the following link: http://www3.best-in-class.com/rr1254.htm.