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.
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.
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.
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.
Regulatory information management
Quality management systems (eQMS)
Regulatory intelligence services/databases
Product lifecycle management (PLM)
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.