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Functional Safety of Medical Devices: Automatic Self-Tests of Computer Components - Examination

Exam1 HourExamination

The aim of functional safety is to design medical devices in such a way that any probable technical defect is detected in advance and does not pose a hazard. With this examination you will certify your knowledge about the standards applicable to functional safety on the subject of computer safety and automatic self-tests of computer components, how to apply that knowledge to the development of your medical devices, and how to select and implement the right techniques for the respective application.

Important: To avoid conflicts of interest that could compromise the impartiality of the Notified Body, we only provide public trainings for MDR and IVDR topics. We do not offer private or in-house training for MDR and IVDR topics.

Who Should Attend?

Manufacturers of active medical devices
Developers (hardware and software) of all medical devices
Employees and managers from research and development
Quality managers, regulatory affairs

Benefits

By successfully passing the examination you will acquire the "Functional safety of medical devices based on Medical Device Regulation (MDR), (EU) 2017/745" certificate by TÜV SÜD Academy. With this certification you can demonstrate you have the knowledge:

Of the standards for functional safety of medical devices.
Increased product safety within the development processes of your medical devices.
How to avoid risks to patients.
Development of medical devices according to the state of the art and reduce liability risks.

Methodology

This is an online proctored examination: Live Proctoring

The 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 examination 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.

Learning Assessments

Exam duration: 45 minutes
Consists of 20 multiple-choice questions
Passing score: 61%
Exam aids: "Closed book" (No learning materials allowed)
By successfully passing the examination you will acquire the "Functional safety of medical devices based on Medical Device Regulation (MDR), (EU) 2017/745" certificate by TÜV SÜD Academy.

FAQs

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.