ANSI/UL 2900 Cybersecurity Testing for Medical Device Manufactures

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Medical Device Cybersecurity Testing for Regulatory Compliance

New Regulatory Guidance for Pre-market submission has been drafted and published by several regulatory agencies, including the US FDA, Health Canada, and the EU Medical Device Coordination Group. These documents are harmonized around the need to perform Cybersecurity verification and validation of network-connected devices and medical device software.

In this training program, we will describe and demonstrate the minimum set of cybersecurity testing activities recommended in the guidance documents. We will provide a description of the testing methods and their use in cybersecurity validation. We will identify the available tools to perform the tests and provide either live or video demonstrations of the testing methods and outputs.

The testing methods will be mapped to best practice methods as well as to standards, including the IEC 62443 and ANSI/CAN/UL 2900 standards.

Outcome

Upon completion of this training, you will:

Understand the minimum cybersecurity verification and validations required to meet international regulatory guidance documents;
Understand the purpose of those recommended activities and how they support cybersecurity design validation;
Be familiar with tools that may be used to perform the recommended testing.

Content

Overview of the international guidance documents and the testing methods recommended
Description of each of the recommended verifications and validations
Demonstration of testing tools, methods, and output
Link of testing methods to international standards

The training format will be classroom presentation, live and video example oriented and interactive.

Target Group

Product Development Engineers
Product Security Designers
Software Developers
Quality Professionals
Regulatory Professionals
IT Professionals interested in Product Development
Technical Marketing Professionals
CIOs/CISOs/IT Executives

The training level is introductory to moderate level, suitable for those with some experience in security risk management and secure design considerations.