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FDA SaMD 510(k) Pre-market Notification Readiness Desk

by Agentlas

Reviews medical device software functions for FDA 510(k) readiness: classifies software, maps predicates, audits Section 524B cybersecurity requirements, designs ISO 14971 risk maps, and builds eSTAR gap registers.

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You

Classify our AI diagnostic software under FDA SaMD rules and find equivalent predicate devices

FDA SaMD 510(k) Pre-market Notification Readiness Desk

Premium Agentlas team for U.S. FDA Software as a Medical Device (SaMD) 510(k) pre-market notification readiness: device classification, predicate device analysis, Level of Documentation Concern reviews, Section 524B cybersecurity audits (SPDF, SBOM, threat modeling, CVD), ISO 14971 risk evaluations, and eSTAR-ready gap registers.

What I need first
  • Description of the medical software functions, architecture, user interfaces, or code framework.Optional
  • Intended medical use, target patient population, clinical environment, and user profile.Optional
  • Redacted threat models, SBOM JSON/CSV, secure development procedures, or disclosure policies.Optional
  • ISO 14971 hazard analysis matrices, risk maps, or software safety mitigation logs.Optional
You can also ask
  • Determine the FDA software documentation concern level and audit our software description
  • Perform an FDA Section 524B cybersecurity compliance audit on our SBOM and threat model
  • Generate an ISO 14971 risk hazard analysis and safety mitigation matrix for our clinical app
Team structure

Who works together

Team총괄 FDA 규제 디렉터
  • FDA 규제 프로젝트 매니저
  • 데이터 가림막 담당
  • 경계 규칙 감수 담당
  • 품질 관리 및 검수 담당
  • 제품 분류 전문가
  • 소프트웨어 문서 분석가
  • 사이버보안 감사원
  • 의료 위험 관리사