Medical Device and Network Connected device Cybersecurity

Dedicated to promoting safe and healthy living and working environments, UL helps safeguard people, products and places in important ways, facilitating trade and providing peace of mind. UL certifies, validates, tests, inspects, audits and develops standards and educates. We provide the knowledge and expertise to help navigate growing complexities across the supply chain from compliance and regulatory issues to trade challenges and market access.

Regulatory Requirements

FDAMany countries have individual documents that outline their guidance on activities that manufacturers should take with medical devices that contain software and can be connected to IT networks through wired or wireless connections such as WiFi, Bluetooth, and even with plain old Cat 5 cable. Included in these guidance documents is information which the FDA is expecting to be included in new 510(k) submissions of medical devices with software and network connections.

Medical Device Cybersecurity Assurance

The UL Cybersecurity Assurance Program (UL CAP) for Network Connectable Components (Health IoT) of Healthcare and Wellness Systems is a suite of solutions based on the FDA approved standards:

  • UL 2900-1:2017 Software Cybersecurity for Network-Connectable Products, Part 1: General Requirements (1st Edition)
  • UL 2900-2-1:2017 Software Cybersecurity for Network-Connectable Products, Part 2-1: Particular Requirements for Network Connectable Components of Healthcare and Wellness Systems (1st Edition)

The UL CAP Evaluation reviews documentation related to processes and products and conducts product evaluation and testing. The UL CAP Certification process evaluates documents and process assessment as well as conducts software testing.

SERVICES

We can do several types of tests and issue an informative report, including:

  • Fuzz, Patch, and Malware TestingCybersecurity
  • Informative, Summative and other testing reports
  • Testing certification
  • Re-testing
  • Training
  • Gap Assessments
  • Product Testing

WHY UL

Global Market Acceptance

  • 120 year business experience
  • Operates in more than 143 countries
  • UL has issued more CB Test Certificates than any other body
  • UL reports and certifications are recognized and accepted around the world
  • UL Marks appear on more than 22 billion products globally
Comprehensive Testing & Certification Services

  • UL offers field evaluations, onsite training and can come to you for testing
  • Full compliance testing/evaluation to pre-scans and other preliminary testing
  • UL has engineers that work with you from design through conception and production
  • UL’s engineers average 10 plus years in the industry
  • UL has over 11 industries business units in the UL company portfolio
Knowledge of Global Standards and Regulatory Requirements

  • Covers many markets ie FDA (US), MFDS (Korean FDA), EU IVD, EU MDD
  • UL has helped to set more than 1,600 standards defining safety, security, quality and sustainability
  • UL Engineers partner with standard committees such as AAMI, ANSI and government bodies
  • UL has an FDA recognized consensus standard, UL 2900, for cybersecurity
State of the Art Facilities

  • 159 UL laboratories for testing and certification world wide
  • Tailored testing solutions, using software automation to enhance process efficiency, analyze results and reduce testing cycles
  • Over 10 Accredited UL laboratories around the world

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