IT Security of Medical Devices Workshop
Johner Institute New Zealand

Date: 30 and 31 May 2023
Time: 9 am – 5 pm
Location: HSBC Centre, 188 Quay Street, Auckland 1010, NZ

Price in NZD: $2,400 plus GST, including morning tea, lunch, afternoon tea and beverages.
The number of participants is limited to 16.

To register, please email [email protected] and we'll provide you with a link.

About the trainer, Tyler Harmon
Tyler Harmon is a medical device consultant with expertise in Software as a Medical Device and Cybersecurity risks to both products and enterprise systems. His clients have included global corporations as well as startup companies. He was especially instrumental in the development and regulatory clearance of Apple's first Machine Learning medical device. Also with Apple, Tyler assisted in extending their ISO 27001 certification to cover the medical device division and leveraging Apple's existing systems to mitigate cybersecurity risks across their portfolio. Additionally, he worked with Draeger Medical throughout the pandemic to address urgent cybersecurity issues, including those brought forth during an FDA 483 Warning Letter. He served as a CAPA specialist as well as a technical architect to help mitigate issues in legacy systems. He also served as the Global Quality System Manager for Software and Cybersecurity at Fisher & Paykel Healthcare, New Zealand's largest medical device manufacturer, where he is charged with ensuring cybersecurity risks are mitigated across both their ICT environment and the product portfolio. There he has successfully led a combined team of software developers and quality engineers in the development and certification of an integrated Information Security Management System that has been certified to ISO 27001 by BSI.

Targets
We would like to explicitly point out that in this seminar we are teaching the regulatory requirements and not the concrete technical implementation of IT Security.

This two-day compact seminar on IT security of medical devices pursues the learning objectives:

• Regulatory requirements
  You know the regulatory requirements for IT security and can classify them according to application areas (e.g. NZ / TGA / EU / FDA / international, industry-specific / non-specific, manufacturer / operator).
• Basic Data Protection Regulation – different countries
  You can place the requirements of the General Data Protection Regulation of the countries in the context of the requirements for the IT security of the products.
• Basics and terms
  You know the protection goals of IT security in the context of medical devices and can confidently handle terms, e.g. threat, vulnerability, asset.
• IT Security-Related System & Software Requirements
  You will receive an overview of the specific IT security requirements (software / system requirements) resulting from the application of the relevant standards and laws.
• Security Analysis
  You can apply methods (e.g. Threat Modelling, Threat Analysis and Risk Assessment) to systematically analyze and minimize IT security risks.
• Security Testing
  You know important test methods in IT security, e.g. penetration testing or fuzz tests
• Development and Post-Market Processes
  You understand how continuous assurance of IT security can be embedded into the development process and post-market surveillance, and what data sources and roles are available for this.

Target group
This seminar on IT security for medical devices is aimed in particular at the following persons:

• (Software) developer and software tester
• Employees in IT
• Regulatory Affairs and Quality Manager
• Risk managers and PRRC (when your device is on the European Market)
• Project Manager and Product Manager

To register and for more information, please contact the Johner Institute at [email protected]