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Best Practice Database
Quality, Compliance and Regulatory » Regulatory Affairs
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Faced with the monumental task of ensuring that companies comply with the plethora of global regulations pertaining to developing and marketing medical device products, Regulatory Affairs 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 conducted this benchmarking study to establish meaningful metrics around Regulatory Affairs' spend, FTEs and consultants for medical device operations in the U.S. and globally. Staff and budget benchmarks are presented per Class I, II and III device products on the market, submissions actively maintained in 2010 and product applications submitted in 2010.
This metrics-heavy study presents spend, FTE and consultant ratios and benchmarks across regions and product types for the medical device industry. Specifically, the research includes spend, FTE and consultant ratios and benchmarks for Class I, II and III products on the market, with ratio data presented as spend per Class I, II and III product, FTEs per Class I, II and III product and consultants per Class I, II and III product.
In addition, the study contains spend, FTE and consultant benchmarks for regulatory submissions being actively maintained in the U.S., Canada, the EU and Japan during 2010. The same regional data is presented for regulatory submissions in 2010.
Medical device regulatory leaders can use this study to compare their spend, FTE and consultant ratios and benchmarks (per product type and by region) with those of leading medical device companies.
Regulatory Affairs Reporting Relationship: For 38% of companies, the Regulatory Affairs function reports to C-level management, or the highest level of senior management. For more than one-third of companies, the Regulatory Affairs function reports into a combined Quality and Regulatory Affairs executive.
Filing Trends: During the past three years, more than half the benchmark class saw increases in 30-day and 180-day supplements, 510(k)s, and Canadian licenses. Overall, non-U.S. filings have increased significantly for 63% of the benchmark class.
For this benchmarking study, Best Practices®, LLC gathered insights and performance data from eight regulatory leaders representing eight leading medical device organizations. In addition, executive interviews were conducted with selected participants to produce qualitative insights.
Consumer Products; Medical Device; Chemical; Technology; Health Care; Pharmaceutical; Orthopaedics
Bausch & Lomb; Edwards Lifesciences; BD; Roche Diagnostics; Boston Scientific; Ethicon; Johnson & Johnson; Medtronic; Zimmer