PreQMS
preqms.com
PreQMS
preqms.comPreQMS is a regulatory readiness platform that uses AI to review medical device requirements against IEC 62304 and FDA 510(k) rules.
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According to AlphaMoat, in the latest data month PreQMS (preqms.com) received 0 monthly visits — ranked #0 of 17,424 AI websites with traffic data, and #0 of 3,134 in Industry Services.

Monthly Visits
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Overall Rank (17,424)
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Industry Services Rank (3,134)
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Top Market
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What is PreQMS

Product Overview

PreQMS is a regulatory readiness platform for medical device software teams. It analyzes design controls, software lifecycle documentation, risk management files, cybersecurity evidence and verification records to measure how close a product is to submission readiness.

Key Features5 items
  • 01Requirements management with AI review built in
  • 02AI flags vague or non-testable requirements against IEC 62304 rules before an auditor does
  • 03Readiness score and gap list rated by severity
  • 04Traceability matrix, formal review and version control
  • 05FDA audit trail and 510(k)-ready Word exports
Business Model

The Free plan is $0 forever; the Starter plan is $999 per month and add-on AI credit packages can be added to paid plans.

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Data month: — · Visit figures are third-party traffic estimates aggregated monthly — best for scale and trends. Multiple domains of the same product are merged. See methodology.