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.
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.
- 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.
- 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.
Faud Khan, Chief Security Analyst, TwelveDot Inc.
Laura Élan, Cyber Security Medical Expert, TwelveDot Inc.