Online Roadshow | Medical Device Cybersecurity Life-Cycle Assessment

In light of the emerging threat of cybercrime leading regulators as the US FDA (Food and Drug Administration) or the European Commission introduced strict security requirements for medical devices, which are mandatory to fulfill in order to successfully obtain market access for the products. Planning a market access to the EU, manufacturers of medical devices are supplementary challenged due to the short transition phase to EU MDR (EU 2017/745) and EU IVDR (EU 2017/746).

To close the gaps between the regulatory frameworks and the industry specific security considerations, a new set of standards and standard families are being adopted and published to specifically address cybersecurity in medical/healthcare application. Managing cybersecurity throughout the entire life-cycle of a medical device is a major challenge that requires, among other things, risk management, threat-modeling and security testing such as penetration testing or vulnerability scanning.
In our online roadshow “Medical Device Cybersecurity Life-Cycle Assessment” we provide you with three sessions to make sure you can participate at a time that is convenient for you. Our experts will address the following topics:

Part 1
  • Fragmentation in the cybersecurity of medical devices in the EU

Part 2
  • What is Cybersecurity?
  • What is the difference to "Information Security"?
  • What are the basic Cybersecurity Elements – CIA?
  • How a cybersecurity test is conducted against medical device and why is it important?

Part 3
  • Medical device security expectations by notified bodies
  • Security Life-Cycle and IEC 81001-5-1:2021 considerations in the product life-cycle
In Asia
June 14, 2022 (Thuesday)   
3:00 pm Peking/Hong Kong
2:00 pm Bangkok
[9:00 am Berlin]

In Europe and the Middle East
June 14, 2022 (Thuesday) 
1:00 pm Berlin
3:00 pm Abu Dhabi/Dubai
5:00 pm Dkaha

In North and South America
June 15, 2022 (Wednesday)
7:00 am San Francisco
10:00 am New York
11:00 am Sao Paulo/Rio de Janeiro
[4:00 pm Berlin]
Kaida Shawn Shotaro
Ferenc Kazinczi
Martin Michelot

Duration: 1.0 hour
Language: English

Our Experts
Kaida Shawn Shotaro
Head of Cybersecurity Services, Asia Pacific & Global Head of TCC, Cybersecurity Testing, Medical and Industrial Robotics, TUV Rheinland Group

Prior to joining TÜV Rheinland, Kaida Shawn Shotaro has held various leadership positions at both large enterprise and startups in Cybersecurity, Telecommunication, Industrial Connectivity Solution providers. He was educated at top universities in Japan, the US, and Korea and speaks 3 languages fluently. Connect on LinkedIn!
Ferenc Kazinczi
Global Head of Medical Software TCC, Active Medical Device Auditor and Medical Software Product Specialist, TUV Rheinland Group

Ferenc Kazinczi has more than ten years international experience in the medical devices industry leading R&D and BD projects in Europe, Japan and US. At TÜV Rheinland he is leading a Medical Software Expert Team focusing on SaMD, Cybersecurity, AI/ML, Cloud and IoT applications for medical devices, defining harmonized assessment, regulatory compliance, testing approaches and identifying new service opportunities. Connect on LinkedIn!
Martin Michelot
Executive Director - Europe at TIC Council

As the executive director of the Europe Regional Steering Committee of TIC Council, Martin Michelot is following a variety of objectives in order to define and supervise an overall advocacy strategy to deploy in Europe. Besides, he is the Deputy Director of the EUROPEUM Institute for European Policy in Prague, and a Non-Resident Fellow at the Paris office of German Marshall Fund of the United States. Connect on LinkedIn!

Your registration

You will receive a confirmation of your registration by e-mail. After the event, we will provide you with the presentation as a download. For questions and further information, we are also available in advance.

There are no participation fees for you by participating in the events. In return for attending, we only request your contact details and your consent to receive regular e-mail updates on TÜV Rheinland products and news in the future. The fields marked with * are required for a region-specific contact to coordinate conversations. This enables us to process your inquiries quickly and competently.

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