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Medical Device and IVD Cybersecurity Foundational training course

Face to face Training1 DayBeginner

This course will provide you with essential knowledge on medical device / IVD cybersecurity. You will get an overview on key terms in cybersecurity and sharpen your understanding of the current US / European regulatory landscape.

This course is part of a modular training concept and functions as a foundational level. Upon successful completion of the respective exam, you will acquire a certificate with the recognized title of “MDR / IVDR Cyber Security Specialist” and hence accomplish authorisation to continue with the advanced modules to finally become “MDR / IVDR Cyber Security Expert”.

At the end of the training there will be an online proctored examination:

Exam duration: 30 minutes
Consists of 15 multiple-choice questions
Passing score: 60%
Exam aids: "Closed book" (No learning materials allowed)
By successfully passing the examination you will acquire a certificate with the recognized title of MDR / IVDR Cyber Security Specialist.
Certificate validity: No limitation

Live Proctoring

The final examination is monitored online in real time by a proctor. Participants can contact the online examination supervisor via the chat function. The instructions of the online examination supervisor must be followed.

Requirements for Live Proctoring Examination:

Students need to connect to the training session from an internet accessible location.
Webcam and Microphone are REQUIRED.
The examination venue must be a self-contained private room or office.
When prompted by the online exam proctor, the complete work environment/room must be shown using the camera.
There must be no other people in the room.
No other materials are allowed in the vicinity of the PC/laptop other than permitted resources.
No texts on the walls or desk.
Quiet surroundings and no music, television or other sources of noise.
No other computers or devices in the room are to be switched on.
The room must be sufficiently lit (equivalent to daylight).
Participants are not permitted to create or distribute transcripts of the examination contents (electronically and/or manually).

The participant undertakes to meet these requirements in full. Failure or refusal to meet these requirements may cause the certification body to issue a result of attempted cheating, deception or disqualify the participant when they review the examination.

Examples:

Participant makes/receives a telephone call during the examination.
Another person appears in the room.
During the examination, the browser displaying the examination is left and answers are researched online despite this being prohibited by the examination regulations (closed book).
Documents/notes are positioned on or around the laptop/monitor that enable the participant to cheat.

In the event of technical problems with the laptop/PC (e.g. PC crashes during the examination) or the Internet connection is disrupted, the examination is deemed terminated and must be repeated. Should this happen, please get in touch with us.

Every examination from TÜV SÜD Academy has its own examination regulations that describe the permitted resources, for instances. There may be supplementary regulations for online examinations. The examination regulation/s and any supplementary regulations shall apply.

Who Should Attend?

This training is intended for the following target group:

➢ Quality Officers

➢ Process Owners

➢ Regulatory Affairs Officers

➢ Managers

Objectives

You will develop a thorough understanding of cyber security basics and of medical device / IVD specific elements.
You will learn about regulatory requirements and acquire basic knowledge regarding the security development lifecycle (SDL), IEC 81001-5-1, risk assessment, threat modelling, vulnerability scanning, penetration testing, and fuzzing. By successfully passing the examination you will acquire a certificate with the recognized title of Cyber Security Specialist.

Agenda

Key terms and motivation
Regulatory landscape
Security development lifecycle
Security risk assessment / threat modelling
Vulnerability scanning / penetration testing / fuzzing
Cyber Security technical documentation
Examination (30 min)

Benefits

Course delivered by one of TÜV SÜD's leading industry experts
Small class sizes enhance trainer-delegate relationship
Receive globally recognised TÜV SÜD certificate upon completion

Methodology

Upon completion you will receive your globally recognised TÜV SÜD Certificate of Attendance in Medical Device and IVD Cybersecurity.

FAQs

TÜV SÜD tests and certifies through its Notified Bodies medical devices and their manufacturers. TÜV SÜD Academy UK offers trainings in the field of medical devices.

The neutrality and independence of the conformity assessment procedures carried out by TÜV SÜD must be maintained. In the interest of our customers, hence the seminars of TÜV SÜD Academy do not contain any product-specific, process-related or company-specific content or solutions that could fulfill the function of individual consulting.

In case of any questions or uncertainties, please do not hesitate to contact us.