Seminar IT Security for Medical Devices and IEC 81001-5-1 (2 days)
Get a head start in knowledge and reduce the risk of IT security incidents to a minimum
In this seminar, as a manufacturer of medical devices, you will learn about the regulatory requirements for IT security and data protection for medical devices and how to implement them professionally in your company.
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11.09.2025
Get an overview of the requirements and learn to deal with them competently
We will first familiarize you with the general protection goals and the most important terms. In the next step, we will introduce you to the most relevant regulatory requirements and the EU General Data Protection Regulation. This enables you to apply the relevant standards and laws to your company concretely and put them into the context of your devices.
100%
of the participants who gave feedback
recommend this seminar!
“The concepts were explained with clarity, and the recommendations are very useful to implement the IT security process.”
Develop an understanding of the concepts of IT security and transfer them effortlessly into practice
Gain an in-depth understanding of IT security concepts and learn about the most important methods and test types. You will be able to use them to analyze and minimize IT security risks systematically and to easily and efficiently embed the continuous assurance of IT security into your business processes.
Benefit from our broad experience from numerous successfully completed projects
Our team implements the regulatory requirements for IT security in medical devices daily in various customer projects and has, therefore, gained much experience with notified bodies and authorities over the years. We want to pass this experience on to you in the seminar.
You can find more information about the seminar and the schedule in the information sheet:
Certificate
There is a voluntary online exam at the end of the seminar (duration: approx. 20 min). By passing this exam, you will receive a certificate proving your newly acquired knowledge and skills in addition to your attendance confirmation.
Further Information
- Relevant regulatory requirements related to IT security
- Distinction between data protection and IT security
- Data protection requirements in the context of a medical device
- Relevant terms and concepts
- Implementation of IT security in the life cycle process of a medical device (IEC 81001-5-1)
- Systematic identification and minimization of IT security risks
- Derivation and formulation of safety-specific product requirements
- Relevant architecture and implementation specifications
- Specific test methods for IT security
- Handling of already approved devices that have not been developed according to current specifications
- deal professionally with the most important terms and concepts of IT security in everyday business.
- develop regulatory-compliant standard operating procedures and document templates.
- create a complete and compliant product file for IT security.
- implement the IT security life cycle process in a compliant manner, including market surveillance.
- Software Development and Architecture
- Quality Management
- Regulatory Affairs
- Management
- Internal Audits, Supplier Audits
- Authorities and Notified Bodies
An invoice will be sent to you within the next 48 hours, with a payment term of 14 days. If this payment term is not feasible for your company, please send a short e-mail to seminare@johner-institut.de to find a solution.
Three days before the seminar, you will receive two e-mails: The first contains the final link to the seminar and the second contains the access data to a cloud folder in which you will find documents for preparation, exercises, and presentations.
At the end of the seminar, you will receive a feedback link for evaluation. The following day, we will send you your certificate of attendance.
Get to know your trainer
As an engineer for biomedical technology, Christian Rosenzweig was responsible for basic and software development for complex active medical devices for many years. As the person responsible for carrying out and guiding conformity assessment procedures in the EU and USA, he gained experience with all forms of audits and various markets (in particular, FDA and MDSAP). He was also an ISO 13485 quality management representative in a large corporation. As a sought-after expert, he assists our customers with strategy issues and the implementation of quality or regulatory affairs management. His focus is on the safety of medical devices, risk management, and IT security.
Are you familiar with our in-house seminars?
We are also happy to offer you our seminars as in-house seminars. Either online or at your premises, as required.
Please feel free to contact us.
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