Medical Device Cyber Security Services

Overcoming the Challenges of securing mission-critical medical devices from the growing cyberthreats and cyberattacks

Medical Device Cybersecurity Services:

  • NIST, FDA, and EU Cybersecurity Mandates and Statutes Compliance.
  • Executive Order (EO) improving the Cybersecurity of the Federal Government (OE 14028) – highlights FDA guidance.
  • Manufacturers are responsible for remaining vigilant about risks and hazards including risks related to cybersecurity.
  • Manufacturers are responsible for putting appropriate mitigations in place to address patient safety risks and ensure proper device performance.
  • The Medical Device Reporting (MDR) regulation (21 CFR Part 803) contains mandatory requirements for manufacturers, importers, and device user facilities to report certain device-related adverse events and product problems to the FDA.

LP3 Cybersecurity:

  • Medical Device Architecture Security Experts
  • Threat Modeling and Security Risk Analysis
  • Security Experts Participate in Design
  • Forensics and Incident Response
  • Cyber Security Penetration and Vulnerability Testing
  • Post-Market Continuous Monitoring and Reporting
  • Supply Chain Risk Management / Third Party Risk Management
  • Medical Device, Enterprise and Document Security
  • Cybersecurity Training & Virtual CISO Services
  • Subject Matter Expert (SME) Certifications – CISSP-ISSAP, ISSMP, Security+ CE, CompTIA A CE, CEH

Topics:

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Additional Continuous Monitoring (ConMon) Support Services

In order to maintain your current compliance status, there are several practices/controls that need to be maintained on a periodic basis.  The following cost-effective services have been developed by LP3 specifically for businesses to meet these requirements:

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