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Cyber Security for Medical Devices Training Course

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. 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.

11 Oct 2022

& 20 Jan 2023 , 28 Apr 2023 , 7 Jul 2023 , 18-19 Oct 2023

Book or reserve now

Details

Overview

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. 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.

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

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

Programme

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

Presenter

Ben Kokx (More...)

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.


Book now

Book or reserve now

NEW higher discounts for booking multiple places - bring your colleagues to make your training budget go further:
30% off the 2nd delegate; 40% off the 3rd delegate; 50% off the 4th delegate

Choose your date below - or reserve your place with no obligation for 7 days at ipi.academy: Reserve now
11 Oct 2022
Live webinar
09:30-17:00
UK (London)
11 Oct 2022
Live webinar
09:30-17:00
UK (London)
GBP 599 499
EUR 859 719
USD 970 814
Until 6 Sep*
Enrol now
to attend Live webinar
20 Jan 2023
Live webinar
09:30-17:00
UK (London)
20 Jan 2023
Live webinar
09:30-17:00
UK (London)
GBP 649 549
EUR 929 789
USD 1,049 893
Until 16 Dec*
Enrol now
to attend Live webinar
28 Apr 2023
Live webinar
09:30-17:00
UK (London)
28 Apr 2023
Live webinar
09:30-17:00
UK (London)
GBP 649 549
EUR 929 789
USD 1,049 893
Until 24 Mar 23*
Enrol now
to attend Live webinar
7 Jul 2023
Face-to-face, Rembrandt Hotel London
09:00-17:00
UK (London)
7 Jul 2023
Face-to-face
Rembrandt Hotel London
09:00-17:00
UK (London)
GBP 749 649
EUR 1,079 939
USD 1,209 1,053
Until 2 Jun 23*
Enrol now
to attend Face-to-face
Rembrandt Hotel London
  • 1 day classroom-based training
  • Meet presenters and fellow attendees in person
  • Lunch and refreshments provided
  • Download documentation and certification of completion
  • Fair transfer and cancellation policy
18-19 Oct 2023
Live webinar
13:30-16:45
UK (London)
18-19 Oct 2023
Live webinar
13:30-16:45
UK (London)
GBP 649 549
EUR 929 789
USD 1,049 893
Until 13 Sep 23*
Enrol now
to attend Live webinar

Learn more about our face-to-face and webinar training formats.

* Note the early booking discount cannot be combined with any other offers or promotional code. As such, discounts for the 2nd/3rd/4th attendees are based on the full price of the course. Please contact us for pricing if you wish to send more than 4 delegates.

Continuing professional development

This course qualifies for 6 hours for your CPD records.
More about CPD

Customised in-house training

We can customise this course to meet the requirements of your organisation and deliver it at your location and/or online.

Contact us

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Previous customers include...

  • Air Liquide Santé International
  • Astellas Pharma Europe BV
  • Becton Dickinson
  • Biocorp
  • Cantab Innovations
  • Chiesi Farmaceutici S.p.a.
  • Chiltern International
  • Cochlear Ltd
  • Dartford & Gravesham NHS Trust
  • Ferring International Center Sa
  • Flextronics Medical
  • Haselmeier AG
  • Medela AG
  • Medicom Innovation Partner
  • Nokia
  • Nordic Semiconductor
  • Novo Nordisk A/S
  • Orthofix s.r.l.
  • PDD Group Ltd
  • Presspart Manufacturing Limited
  • Presspart Manufacturing Ltd
  • Sagentia Limited
  • Sensium Healthcare Ltd
  • SHL Group
  • Smith & Nephew
  • Springboard
  • Team Consulting
  • Team Consulting Ltd
  • Vectura Ltd
  • Weidmann Medical Technology AG

[Ben was] absolutely competent on the topic from multiple standpoints - great choice

Andrea Forcolin, R&D Development Manager, Orthofix srl, Apr 22

A lot of focus on describing status of industry and issues but little insight into innovations and technical solutions. Some talks lacked technical depth with was disappointing.

James Gani, Design Team Leader, SPD Development Company Ltd, Jun 17

Very well organised and a nice broad range of topics. Some very good speakers and interesting talks.

David Harris, Scientist and Inventor, PA Consulting, Jun 17

Quality of speakers and ability to present very good.

Stefan Gaul, Head of Strategic Product Management, Haselmeier AG, Jun 17

I feel the course was very useful and provided an good understanding of connectivity in medical technology and has opened my mind to the many challenges but benefit of connectivity in medical technology.

Paul Fitton, Regulatory Affairs Specialist, Presspart, Jun 17

Very good

Arun Sarda, Global Director, QA & Regulatory Affairs, Presspart Manufacturing Ltd, Jun 16

Provides wide overview, interesting presentations, well prepared speakers

Stefan Gaul, Head of Strategic Product Management, Haselmeier AG, Jun 16

Good

Arnaud Guillet, Business Development Director , Biocorp, Jun 16