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.
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
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.