Seminar IT Security for Medical Devices and IEC 81001-5-1

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.

Next Seminar

13.05.2025
-
14.05.2025

IT security for medical devices and IEC 81001-5-1 (English)

Speaker: Christian Rosenzweig

Location: Online Seminar

Language: English

Seats available

Your Price

1600 €

plus VAT.

1904,00 € (incl. VAT.)

Date	Title	Speaker	Location	Language	Price (plus VAT)	Registration
01.07 - 02.07.2025	IT-Sicherheit für Medizinprodukte und IEC 81001-5-1 (zweitägig)	Christian Rosenzweig	Online Seminar	Deutsch	1600 €	Sign Up
10.09 - 11.09.2025	IT-Sicherheit für Medizinprodukte und IEC 81001-5-1 (zweitägig)	Christian Rosenzweig	Online Seminar	Deutsch	1600 €	Sign Up
04.11 - 05.11.2025	IT-Sicherheit für Medizinprodukte und IEC 81001-5-1 (zweitägig)	Christian Rosenzweig	Online Seminar	Deutsch	1600 €	Sign Up

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

The seminar covers the following topics:

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

After the seminar, you will be able to:

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.

This seminar is designed for people in the field of:

Software Development and Architecture
Quality Management
Regulatory Affairs
Management
Internal Audits, Supplier Audits
Authorities and Notified Bodies

Participants can follow this seminar well even without any special prior knowledge. An understanding of their own medical devices is helpful.

After registering, you will receive a confirmation email containing the meeting link, the time, and information about the participants.

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.

Our online/remote seminars are conducted via the video conferencing tool MS Teams. We recommend dialing in 20 minutes before the seminar begins so that any technical problems can be resolved in good time. If you have any questions or encounter any issues, our team is always available to help.

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.

If you experience technical problems while participating or have any other questions, you can contact our support team anytime, even at short notice. The documents provided also include an emergency number to help you in urgent cases.

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.

Do you have any further questions?

Send us an e-mail to seminare@johner-institut.de.

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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

Get an overview of the requirements and learn to deal with them competently

Develop an understanding of the concepts of IT security and transfer them effortlessly into practice

Benefit from our broad experience from numerous successfully completed projects

Certificate

Further Information

Get to know your trainer

Are you familiar with our in-house seminars?

Do you have any further questions?

Datenschutz

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