Medical Device Regulatory Survey Report 2024
Our survey covered key topics such as current challenges, resource allocation, advanced technologies, and regulatory processes to provide a clear picture of where the industry is headed.
The survey findings have been compiled into actionable insights for better decision-making in regulatory affairs and compliance.
Take a sneak peak at the key insights from the survey, highlighting the top challenges and trends in medical device compliance.
10% of RA/QA teams report version control issues, while over one-third face challenges with costs and resources for QMS.
34% of device makers are confident in maintaining compliance, but 16% need cost-effective solutions, and 20% require pre-submission support.
Only 6% rate their regulatory processes as comprehensive, with 65% admitting minimal or reactive compliance monitoring.
Bandwidth is the top challenge for over a quarter of teams, and only 21% feel they have enough resources for 2024 priorities.
Nearly one-third of companies have no plans to adopt advanced regulatory technologies due to high perceived costs and limited knowledge.
One-third of companies use RWE, but many struggle with data collection, analysis, and integration.
For further regulatory assistance or queries on how Celegence can support your organization, reach out to info@celegence.com today.
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