Core Insights - Veeva Systems' 2025 Medtech Regulatory Affairs Benchmark reveals that 50% of respondents lack full confidence in their data completeness for global product registrations, leading to increased administrative burdens for regulatory teams [1][2] - The report highlights that only 17% of respondents rate their regulatory data quality as excellent, indicating a significant opportunity for improvement in data management and automation [2] - The survey of 130 regulatory professionals identifies heavy administrative burdens (61%), siloed processes (49%), and digital tool proficiency (35%) as major challenges hindering regulatory efficiency [5] Regulatory Operations - The lengthy timelines for submission preparation are concerning, with 80% of respondents indicating that preparing a submission for a 510(k) takes a month or longer, and 24% stating it takes more than six months [5] - Organizations are spending up to two years on each MDR submission, suggesting that reducing submission timelines could lead to faster market entry and significant cost savings [5] - Only 5% of respondents utilize a fully automated process to monitor time to market, with about 67% relying on manual processes, complicating performance insights [5] Technology Adoption - There is a growing trend towards adopting regulatory information management (RIM) systems, with 56% of organizations planning to implement such systems to enhance efficiency and compliance [5] - Nearly half of the respondents (52%) are looking to develop integrations between existing systems, and 48% are interested in automated submission tracking and reporting tools to improve data accessibility [5]