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Single User: Authorizes use by the person who places the order or for whom the order was placed.
Sitewide: Authorizes use of the report for a geographic site. All people at site can view the report for a year and copies can be printed.
Corporate: Authorizes use for the entire company for a year and copies can be printed. No limitations for usage inside the company.
Best Practices, LLC conducted this benchmarking study to establish meaningful metrics and insights around the structure, activities, roles and responsibilities of Regulatory Affairs groups at medical device companies. The study also provides recent spend and staffing trends of regulatory affairs in medical device sector, including the use of outsourcing and off-shoring.
Medical device regulatory leaders can use this study to align their staff as per strategies of best in class companies for an increased performance delivery.
The report is based on the qualitative and quantitative insights of 8 executives from 8 medical device companies. Additionally, three executives shared their knowledge and experiences through deep-dive interviews.
Sample Key Findings
Corporate Regulatory Affairs Groups: Corporate Regulatory Affairs groups average seven FTEs. The groups primarily promote standards, monitor the worldwide regulatory environment, coordinate internal and external policy advocacy efforts, and advise business unit Regulatory Affairs staff.