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Quality, Compliance and Regulatory » Structure,Staffing and Execution
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Best Practices, LLC conducted this study to establish evidence-based benchmarks describing performance levels, approaches and boundaries - as well as to capture forward-looking insights about high-performance in the Regulatory Affairs function at medical device companies. In particular, the study identifies key performance indicators for regulatory budget, staffing, submissions trends, management factors, critical regulatory roles, responsibilities and off-shoring/outsourcing trends. Also, it highlights current and future trends shaping the Medical Device Regulatory Affairs function.
Best Practices, LLC recruited Regulatory Vice Presidents and Executives at 32 leading medical device companies to share quality data and regulatory insights regarding current and future trends influencing Regulatory Affairs.
Segmentation analysis was key to examining trends and effective practices. Primary analysis concentrates on larger companies, often segmenting them by product portfolio complexity. Portfolio complexity was assessed by Ratio of Class III products, which emerges as a key driver of regulatory resources employed. Participating companies range in size from $300 milllion to more than $25 billion. Response data from some smaller companies (less than $300 million in revenue) were considered to analyze general regulatory trends and emerging issues.