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Medical Device and IVD Cybersecurity Foundational Training Program

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

At the end of this training,

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.

Important: TÜV SÜD tests and certifies through its Notified Bodies medical devices and their manufacturers. TÜV SÜD Akademie GmbH 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 Akademie 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 at [email protected].

This training is intended for the following target group:

Quality Officers
Process Owners
Regulatory Affairs Officers
Managers

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)

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 authorization to continue with the advanced modules to finally become “MDR / IVDR Cyber Security Expert”.

This Instructor-led in a virtual classroom course is part of a modular training concept and functions as foundational level. Participants in this training receive a Certificate of Attendance by TUV SUD Academy.

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.

There will be an online proctored examination at the end of the training program:

Exam duration: 30 minutes
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

What is a proctored exam?

A proctored exam is an assessment supervised by a proctor or test monitor.

What is an online proctored exam?

An online proctored exam is a timed assessment via an online platform in which the candidates’ activity, webcam video, and audio are monitored. In our case, there is a human proctor that supervises the exam taking place via a webcam to ensure the authenticity of the test taker and prevents them from cheating.

What is a proctor?

A proctor is simply an invigilator whose job is to overlook test takers during examinations for the main purpose of ensuring that they don’t cheat. This is done with the help of a real-time test proctor present online during the duration of the assessment via webcam surveillance.

What is proctoring?

Also known as invigilation, proctoring is the act of supervising candidates during an examination. The purpose of this is to ensure that the exam process is fair and equal for all candidates. When the stakes are high, it’s crucial to guard against cheating, impersonating a candidate, or copying questions to share with others.

How do proctored online exams work?

Online proctored exams are timed exams that are taken online while the proctor monitors the test takers’ computer browser activity, webcam video, and audio during the exam.

But before the test begins, the candidate is required to fill in their details like name, date of birth, age, and gender to ensure their authenticity. The test taker is expected to show ID proof for facial recognition. In the same step, the microphone and webcam are tested to avoid any errors during the assessment.

Once the ID verification has taken place, checks are conducted on the candidates’ exam environments to prevent any cheating from taking place.

The rules of the online proctored exam are explained to the candidates. This typically includes things like no speaking, referring to notes, using other software on a computer or copying down exam content to share with others. Once that is done, then the real assessment can begin.

During the assessment, the candidates are monitored to ensure that they follow the rules.

Each of these steps is designed to ensure that the assessment is completely fair and prevent any test fraud from taking place.

The proctor will authenticate students’ IDs, keep track of time, and watch students to make sure that they are following test guidelines and instructions.

Medical Device and IVD Cybersecurity Foundational Training Program

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