Intelligent Navigation for the Regulatory Environment
Utilizing AI for successful regulatory clearances and approvals...
Nearly 50% of an organization's product development budget may ultimately be devoted to achieving FDA regulatory clearance or approval. We are working to ensure the likelihood of success through the initial submission and accelerate the commercialization of medical products.
30%*
of 510(k) submissions were placed on Refuse to Accept (RTA) hold because they lacked the appropriate level of detail
20%*
of 510(k) submissions did not pass the initial review for completeness
19%*
of 510(k) submissions do not follow or address current Guidance Documents or Recognized Standards
13%*
of 510(k) submissions had missing or non-compliant testing information
*FDA and consultant information on file
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