Showing 31 of 31 firms
Start an RFPCompliance & risk. Healthcare cybersecurity risk assessment. HIPAA and FDA compliance programs.
Services: Healthcare cybersecurity risk assessment · HIPAA and FDA compliance programs · Medical device security risk management
Coverage: US, national · HQ Irvine, CA
Regulatory consulting. FDA premarket cybersecurity consulting. 510(k)/PMA regulatory strategy.
Services: FDA premarket cybersecurity consulting · 510(k)/PMA regulatory strategy · Regulatory submission support
Coverage: US, national · HQ Austin, TX
Device security engineering. Medical device penetration testing. Premarket security engineering.
Services: Medical device penetration testing · Premarket security engineering · SBOM and vulnerability assessment
Coverage: US, national · HQ Miami, FL
Device security engineering. Medical device vulnerability testing (DeviceSecure). Device security research and assessment.
Services: Medical device vulnerability testing (DeviceSecure) · Device security research and assessment · Premarket security support
Coverage: US, national · HQ Columbus, OH
Device security engineering. Medical device cybersecurity testing. SBOM and threat modeling support.
Services: Medical device cybersecurity testing · SBOM and threat modeling support · Premarket cybersecurity documentation
Coverage: US, national · HQ Skippack, PA
Device security engineering. Medical device security evaluations. Device vulnerability and penetration testing.
Services: Medical device security evaluations · Device vulnerability and penetration testing · FDA cybersecurity guidance analysis
Coverage: US, national · HQ Menlo Park, CA
Regulatory consulting. Medical device software regulatory consulting. SBOM and cybersecurity documentation.
Services: Medical device software regulatory consulting · SBOM and cybersecurity documentation · FDA premarket cybersecurity guidance support
Coverage: US, national · HQ Toledo, OH
Device security engineering. Medical device cybersecurity testing. UL 2900 and IEC 81001-5-1 evaluation.
Services: Medical device cybersecurity testing · UL 2900 and IEC 81001-5-1 evaluation · Premarket cybersecurity documentation review
Coverage: US, national · HQ Northbrook, IL
FDA premarket cybersecurity. FDA premarket cybersecurity (510(k), De Novo, PMA, eSTAR). Medical device penetration testing and SBOM risk management.
Services: FDA premarket cybersecurity (510(k), De Novo, PMA, eSTAR) · Medical device penetration testing and SBOM risk management · Threat modeling aligned with AAMI SW96 and ISO 14971 · FDA deficiency response with 48-hour gap analysis +1 more
Coverage: US, national · HQ Not published
Engagements: 1 documented, latest in Medical devices
Medical device penetration testing and cybersecurity services, documented from public research.
Services: Medical device penetration testing · FDA 524B cybersecurity support
Cybersecurity services for medical devices, documented from public research.
Services: Medical device cybersecurity · FDA 524B cybersecurity support
FDA compliance consulting for connected medical devices, documented from public research.
Services: FDA 524B compliance consulting · Medical device cybersecurity
Medical device cybersecurity consultancy, documented from public research.
Services: Medical device cybersecurity · FDA 524B cybersecurity support
FDA-focused medical device cybersecurity consulting, documented from public research.
Services: Medical device cybersecurity · FDA 524B cybersecurity support
Regulatory and cybersecurity consultancy for medical devices, documented from public research.
Services: Medical device regulatory consulting · Cybersecurity documentation
FDA regulatory consulting for medical devices including cybersecurity documentation, documented from public research.
Services: FDA 510(k) regulatory consulting · Cybersecurity documentation
Medical device cybersecurity testing lab, documented from public research.
Services: Medical device cybersecurity testing · Penetration testing
Medical device software and cybersecurity engineering, documented from public research.
Services: Medical device cybersecurity · Secure software engineering
Medical device cybersecurity consulting with software expertise, documented from public research.
Services: Medical device cybersecurity consulting · Software forensics
Medical device security risk assessments and penetration testing, documented from public research.
Services: Medical device security risk assessment · Penetration testing
Medical device cybersecurity firm founded by former FDA reviewers, documented from public research.
Services: FDA 510(k) cybersecurity · Threat modeling · SBOM management · Incident response readiness review
Medical device cybersecurity consultancy, documented from public research.
Services: FDA cybersecurity strategy · SBOM preparation · Risk assessments · Postmarket cybersecurity
Healthcare risk platform vendor with medical device incident response guidance, documented from public research.
Services: Incident response planning for medical devices · FDA 510(k) testing guidance · Postmarket surveillance
Penetration testing firm serving FDA 510(k) submissions, documented from public research.
Services: FDA 510(k) penetration testing · Cybersecurity risk management · Compliance testing
Cybersecurity consultancy for FDA 510(k) submissions, documented from public research.
Services: FDA 510(k) compliance services · Penetration testing · Vulnerability resolution
CREST-accredited penetration testing firm serving FDA 510(k) submissions globally, documented from public research.
Services: FDA 510(k) readiness assessment · Vulnerability assessment and penetration testing · Gap analysis
UK/US consultancy for medical device software FDA submissions, documented from public research.
Services: FDA 510(k) submission consulting · Cybersecurity documentation · Labeling and Part 11
FDA regulatory consultancy with 45 years and 1,800+ submissions, documented from public research.
Services: 510(k)/PMA submissions · Software penetration testing · Warning letter response
Medical device cybersecurity firm with the ARIANNA compliance platform, documented from public research.
Services: SBOM/HBOM management · Continuous vulnerability monitoring · 510(k)/PMA submission support
UK-based MedTech cybersecurity firm, documented from public research.
Services: Medical device penetration testing · FDA 510(k) cybersecurity controls · Post-market compliance
UK firm specializing in medical device incident response planning, documented from public research.
Services: FDA 510(k) incident response planning · HIPAA intersection · SaMD and connected device security