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In the midst of growing regulatory complexity, are regulatory affairs teams and processes keeping pace? How should RA teams be staffed? How long should it take to complete a registration or license renewal?
The regulatory performance report takes a deep look into the state of medtech regulatory affairs to answer these and many more critical questions.
Read on to see how your organization stacks up.
Team Size and Staffing
56% of medtech companies have less than 10 full-time employees focused on regulatory affairs. While RA leaders are satisfied with resourcing, front-line employees are feeling the pressure. Headcount planning decisions rarely take into account anticipated workload.
Workload
Time to complete regulatory activities
Average time to complete a license renewal
Average time to complete a license update
Average time to complete a new market submission
The average medtech company completes 50 license renewals, 50 license updates, and 10 new market submissions each year. More than half of these projects take more than 4 months to complete. New market submissions often have 7 or more turn-arounds with health authorities.
Performance
Non-compliance issues in the past two years
Over half of regulatory professionals believe they have the capabilities and processes in place to execute effectively. Yet 61% reported a major non-compliance incident in the past 2 years, with many incurring costs over $1,000,000.
Technology Adoption
Software productivity gains
Regulatory information management
Quality management systems (eQMS)
Regulatory intelligence services/databases
Product lifecycle management (PLM)
Very High
High
Medium
Low
88% of medtech companies have adopted tools that are designed to support regulatory and regulatory-adjacent processes (RIM, eQMS, PLM, Regulatory intelligence). Of these investments, RIM systems provide the highest productivity gains.
