CHAPEL HILL, N.C., Sept. 24, 2018 /PRNewswire/ -- Medical device and technology companies devote significant resources to ensure their products meet quality standards and regulations at every stage of the product life cycle, from research and development and product development through manufacturing, sales, and post-market activity. Increasingly, companies are challenged to ensure quality and safety while managing costs and assessing risk.
Best Practices, LLC undertook this benchmarking research to provide insights into how medical device companies are allocating resources in quality, regulatory affairs, and post market surveillance functions. Furthermore, this study highlights the number of CAPAs, NCEs, field actions, change requests, and complaints that participating companies experience.
"Overcoming Medical Device Resource & Competitive Demands in Quality Assurance, Regulatory Affairs and Post Market Surveillance" is a 39-page study that delivers benchmarks regarding:
- Quality Resourcing and Span of Control
- Operations of Quality Systems
- Regulatory Affairs Operations and Resourcing
- Post Market Surveillance Operations and Staffing
The study found that the combined quality function accounts for almost 8 percent of all company FTEs (5.8 percent on quality assurance, 1 percent on regulatory affairs, and 0.8 percent on post-market surveillance).
This benchmarking report will help medical device leaders ascertain appropriate staff and budget for quality, regulatory affairs, or post market surveillance function(s).
For this research, Best Practices, LLC engaged 33 industry professionals from 31 companies through a benchmarking survey and one-on-one telephone interviews. All data has been aggregated for confidentiality purposes.
To learn more about this report, download a complimentary report excerpt at http://www.best-in-class.com/rr1512.htm.
For related research, visit the Best Practices, LLC Web site at www.best-in-class.com/.
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.
SOURCE Best Practices, LLC