Functional Safety of Medical Devices (Examination - Retake only)
This examination validates your competence in the functional safety of medical devices, with a specific focus on computer safety and automatic self‑tests of computer components. The aim of functional safety is to ensure medical devices are designed so that probable technical defects are detected early and do not pose hazards during use.
This retake-only option is provided exclusively for participants who need to reattempt the examination.
By completing and passing the examination, candidates demonstrate knowledge of:
- The standards related to functional safety of medical devices.
- Methods to increase product safety within development processes.
- Approaches to designing medical devices according to state‑of‑the‑art requirements to reduce liability risks.
Successful participants are awarded the “Functional Safety of Medical Devices based on Medical Device Regulation (MDR), (EU) 2017/745” certificate issued by TÜV SÜD Academy.
Please be mindful, the examination retake is for participants who have previously taken the TÜV SÜD Functional Safety of Medical Devices: Automatic Self-Tests of Computer Components training.
This exam is intended for professionals involved in the development of medical devices, including:
- Hardware and software developers
- R&D engineers and managers involved in medical device development
Building on this, we will provide you with knowledge on the subject of computer safety and automatic self-tests of computer components. You will learn about the challenges of selecting and implementing the right techniques for the respective application.
- You will acquire knowledge of the standards for functional safety of medical devices.
- You will achieve increased product safety within the development processes of your medical devices.
- You avoid risks to patients.
- You develop according to the state of the art and reduce liability risks.
Exam Format
- Duration: 1 hour
- Delivery: Online, proctored in real time
- Candidates may communicate with the online proctor via chat.
- Participants must follow all instructions provided by the examination supervisor.
- A suitable private testing environment is required (see exam requirements below).
Online Examination Requirements
Participants must ensure:
- A self-contained private room or office free from interruptions
- The entire room and workspace can be shown via webcam upon request
- No materials present except those explicitly allowed
- No other electronic devices powered on nearby
- A quiet environment free of background noise
- Adequate lighting equivalent to daylight
- Full compliance with all online proctoring instructions
Violations (e.g., phone calls during the exam, failure to follow requirements, presence of unauthorized materials) may lead to disqualification or a finding of attempted cheating. Participants are prohibited from creating or distributing any exam content.
- 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.
Included with your online training course is one attempt to earn your TÜV SÜD certification. If you are not successful at your first attempt, a certificate of attendance will be granted. If you are looking to obtain your certificate of achievement/completion, please be mindful that you must pay a fee to retake the exam. Please contact us at [email protected] for more information.
What is the Retake Policy for the final examination of the "Functional Safety of Medical Devices: Automatic Self-Tests of Computer Components" training?
- After you complete your training course, the first time the exam is taken is considered a “first attempt” and not a retake.
- If a certification exam is not successfully completed on the first attempt, there is no waiting period before taking the exam a second time.
- A second attempt (first retake) of an exam can be done immediately after the first attempt for a fee of $275 USD.
- Third and further attempts at taking this exam can be done for a fee of $750 USD each attempt.
- Once you pay the retake fee, you’ll be able to schedule the date to retake the exam accordingly to the available date options in our exam schedule.
- Please be mindful that there is a 1-year maximum deadline for an exam retake.