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].
Who Should Attend?
This training is intended for the following target group:
- Quality Officers
- Process Owners
- Regulatory Affairs Officers
- Managers
Course Agenda
- 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)
Course Description
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.
Benefits
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”.
Methodology
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.
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”.
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
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).
- 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.
Learning Assessments
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