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

This training program is designed for:

• Medical device manufacturers (especially active devices)
• Hardware and software developers
• R&D engineers and managers
• Quality assurance and regulatory affairs professionals

• 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

What You’ll Learn

Through real-world case studies—including infusion pumps, insulin pumps, and other critical devices—you will learn how failures can lead to recalls, injuries, or safety notices, and how proper safety design prevents these outcomes.

Core Functional Safety Concepts

• Principles of functional safety and risk reduction
• Hazard, risk, and failure analysis
• Random vs. systematic failures in hardware and software
• Fault tolerance, redundancy, and diversity architectures
• The concept of single fault condition and safe state

Standards & Regulatory Framework

• MDR (EU 2017/745) and General Safety & Performance Requirements
• IEC 60601-1 (Basic Safety and Essential Performance)
• IEC 61508 and ISO 14971
• IEC 62304 for medical device software

Safe System Architecture Design

• Control vs. protective system strategies (CP / CPP structures)
• Fault detection timing (FTT, MFOT)
• Alarm systems and safe shutdown mechanisms

Automatic Self-Test Strategies (Key Differentiator)

• Black-box vs. partitioned testing approaches
• Microcontroller self-tests (CPU, RAM, peripherals)
• CRC, memory integrity, and error detection methods
• Watchdog design and validation
• Program flow monitoring and software safety techniques
• Sensor and analog I/O validation
• User interface and alarm verification

• Improve patient safety by proactively managing failures
• Design devices aligned with state-of-the-art expectations
• Reduce product liability risks
• Strengthen compliance with global standards
• Gain practical, implementation-focused knowledge

What Makes This Course Unique

• Combines functional safety fundamentals + deep technical implementation
• Strong focus on automatic self-tests and embedded system validation
• Based on real device failures and industry best practices
• Designed by TÜV SÜD subject matter experts

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.

Successful participants who attend at least 90% of the total training duration will receive a Certificate of Attendance.

The program culminates with an online proctored examination. If you pass the exam, you will receive a Certificate of Achievement from the TÜV SÜD Academy:

• Achieve the TÜV SÜD Functional Safety Certificate
• Certificate aligned with MDR (EU 2017/745) expectations
• 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 / $375 CAD.
• Third and further attempts at taking this exam can be done for a fee of $750 USD / $1,035 CAD 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.

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.

A basic understanding of medical devices, electronics, or software development is helpful. However, the course starts with fundamentals and builds up to advanced topics, making it accessible to both intermediate and experienced professionals.

1. What is this training about?

This course focuses on functional safety in medical devices, with a special emphasis on automatic self-tests of computer components. You will learn how to design systems that detect and manage faults before they become hazardous to patients.

2. Why is functional safety important for medical devices?

Functional safety ensures that devices remain safe even when failures occur. It helps manufacturers prevent hazards, reduce risks to patients, and comply with global regulations such as MDR and IEC standards.

3. What standards and regulations are covered?

The course covers key standards and frameworks, including:

• MDR (EU 2017/745)
• IEC 60601-1 (Basic Safety & Essential Performance)
• IEC 61508 (Functional Safety)
• IEC 62304 (Medical device software)
• ISO 14971 (Risk management)

4. What makes this course different from other safety trainings?

This course stands out by combining:

• Theory + real-world case studies
• Deep focus on self-test strategies and embedded systems
• Practical insights into failure detection, watchdogs, and system architectures
• Guidance aligned with state-of-the-art expectations and standards

5. What will I be able to do after completing the course?

After completion, you will be able to:

• Apply functional safety principles to medical devices
• Design systems that are safe under fault conditions
• Implement automatic self-tests and monitoring mechanisms
• Support compliance and reduce product risk

6. Will I receive practical examples during the course?

Yes. The course includes real-world examples and case studies, helping you connect theory to actual medical device applications and understand how failures occur in practice.

7. Can I interact with the instructor?

Absolutely. The live virtual format allows you to ask questions, participate in discussions, and engage directly with experts throughout the course.

8. Is this course suitable for my industry or device type?

Yes. The principles of functional safety apply to all types of medical devices, especially those involving electronics, software, and programmable systems.

9. Does this training include consulting or project-specific advice?

No. The course provides general best practices and knowledge. It does not include company-specific consulting, ensuring neutrality and independence.