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Best Practice Database
Quality, Compliance and Regulatory » Structure,Staffing and Execution
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Regulatory Affairs groups guide their organization through the regulatory labyrinth that companies must navigate as part of developing and marketing medical device products. These specialized groups rely on their own internal effectiveness and efficiencies to remain productive. Optimal resourcing and staffing help Regulatory Affairs groups in the medical device industry prioritize roles and responsibilities that will be most beneficial to growth.
Best Practices, LLC undertook benchmarking research to establish evidence-based benchmarks for medical device companies around regulatory budget, staffing and responsibilities. The study also identifies key offshoring/outsourcing trends.
Regulatory Affairs leaders can use this study to compare their function’s staffing and investment pattern with those of leading medical device companies.
· Investment & Staffing
· Regulatory Offshoring & Outsourcing Trends
· Regulatory Spend Trend vs Filing Volume Trend
· Staff Time Invested in Change Management
· Investment Trend Changes
· Outsourced Activities
SAMPLE KEY FINDINGS
• Outsourced Activities: Audit & advisory services -- along with submissions’ related activities -- are the most commonly outsourced responsibilities. Audit & Advisory combined make up 56% of RA services that are most commonly outsourced. Others outsource some technical and overflow work. Some companies (13% of class) don’t do any outsourcing.
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.