Cyber Security for Medical Devices Training Course (October 11, 2022)

Dublin, Sept. 28, 2022 (GLOBE NEWSWIRE) -- The "Cyber Security for Medical Devices Training Course" conference has been added to's offering.

This seminar will provide you with an understanding of cybersecurity and its increasing regulatory focus and how to embed and apply state-of-the-art security in your existing processes to deliver safe and secure products and solutions.

The impact of Cyber Security incidents on society is high, and in critical infrastructures such as healthcare, it impacts the ability for hospitals to provide care. Cybersecurity for medical devices is not just about safety, it should also protect the confidentiality, integrity and availability of systems and data.

Benefits in Attending

  • Gain a comprehensive overview of the EU, US and global regulations
  • Introduction to the various healthcare security standards and their application
  • Best practices on how to embed security by design in existing processes
  • Receive practical advice on threat modelling
  • Better understand security risk management and its linkage to safety management
  • Understand shared responsibility and the information needs

Who Should Attend:

  • Security, Privacy Specialists
  • Risk Managers and Architects
  • R&D, Product and Project Managers
  • Regulatory Affairs and Quality Managers
  • Healthcare IT Consultants and Auditors

Key Topics Covered:

Introduction and Welcome

  • Regulatory versus market expectations
  • Direct and indirect requirements and risks
  • Relationship with best practice

What is Cybersecurity?

  • An intro to Cybersecurity (CEO/FCO fraud, vulnerabilities, ransomware, attackers, etc.)
  • The different perspectives (Hospital, Policy Makers and Regulators, Manufacturers, Patients)

Cybersecurity Regulatory Overview

  • For the manufacturer (both medical and non-medical)
  • For the user (hospital)
  • US Focus (FDA, Bidens Executive Order on Improving the Nation's Cybersecurity)
  • EU Focus (MDR, MDCG Guidance and upcoming NIS2)
  • Global Focus (IMDRF and guidance's around the world)

Security Management Considerations

  • Process, People and Product
  • Product vs Services
  • Mobile apps and complex solutions
  • Development model (Waterfall, Agile, DevOps)

Security Standards

  • For processes
  • For products (MD and SaMD)
  • For health and wellness apps
  • For services and cloud
  • For hospitals
  • Security certifications

Security by Design

  • An introduction to IEC 81001-5-1:2021 Health software and health IT systems safety, effectiveness and security - Part 5-1: Security - Activities in the product life cycle
  • Supply chain
  • Secure coding
  • Testing
  • Monitoring
  • Coordinated vulnerability disclosure
  • Obsolescence/Security updates

Security Risk Management

  • Methodologies
  • Introduction to threat modeling
  • Relation to safety risk management

Further Security Considerations

  • Security in the development, manufacturing and service environments
  • Shared responsibility
  • Security information, e.g., MDS2

Interactive Discussion Q & A


Ben Kokx

Ben Kokx joined Philips in 2001 as a software designer. He quickly moved into a new role as a product security and privacy officer and worked as such in several business and market positions. As Director Product Security within the central Philips Product Security Office, he is responsible for security related standards and regulations next for the Philips Product Security Policy and Process Framework since 2013.

Ben is a healthcare and IoT security expert who leads and participates in several industry associations and standard development organizations like ISO/IEC JTC 1/SC 27, IEC ACSEC, IEC TC62/ISO TC 215, IEC TC65, ETSI TC-CYBER and others. He is the convenor of CEN/CENELEC JTC 13/WG 6 on product security. Ben is an ENISA eHealth cybersecurity expert, chairs the COCIR Cybersecurity focus group and through DITTA, participates in several public-private organizations such as the IMDRF cybersecurity workgroup.

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