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

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

• Basics of functional safety
• Legal requirements, standards
• Failure modes
• History and concept of functional safety
• Fault assumptions and exclusions
• Safe architectures
• Self-tests
• Common-mode faults
• PEMS and IEC 62304
• Microcontroller self-tests
• Software tests
• Test of analog components
• User Interface
• Visual and audible alarm
• Software and software update
• Remote control of medical devices, telemedicine
• Examples
• Final Exam

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.

This is an instructor-led training in a virtual classroom which culminates with an online proctored examination. This means the course is Live Online. Participants will learn through online teaching. Lectures, case studies, group exercises, discussions, problem solving, examples with explanation, assignments and/or quizzes happen in the virtual classroom training. Participants need to connect to the class from any internet accessible location. Each module is delivered live using webinar technology, creating a virtual classroom learning environment. Live sessions provide you with direct access to the trainer so you can ask questions, understand complex concepts and share ideas with peers. Webcam and microphone are REQUIRED to interact with the instructor and/or other participants.

The course content and structure are designed by the domain experts from TÜV SÜD. With immense experience and knowledge in the relevant standards, our team of product specialists and technical experts at TÜV SÜD, developed the course content based on current business landscape and market requirements.

Online proctored examination: Live Proctoring

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).

• 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.

• Final 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.