Software developers face the challenge of meeting the strict legal requirements for IT security of medical and IVD medical devices. Without the right skills and tools, it often leads to time-consuming rework, costly delays, and problems during audits. That can jeopardize projects and delay market launch.
This customized in-house workshop provides your software development team with the skills they need to develop secure (IVD) medical devices. The focus is on practical application, from specific coding guidelines to development tools. The contents are specifically tailored to the MDR, IVDR, and IEC 81001-5-1 requirements.
This training is special because it is offered specifically for your programming language and platform. This way, you can put what you have learned into practice immediately and develop secure, legally compliant code right from the start.
Send us an e-mail to [email protected] to book the in-house workshop for your company.
The workshop is specially designed for software developers and provides knowledge directly at the code level. You will learn exactly what you need for secure and legally compliant software – in programmer's language.
We have not yet received any written feedback on this workshop.
The training is tailored to your programming language and platform. That enables the direct implementation of what you have learned and the development of secure code right from the start.
You avoid costly rework and delays by acquiring the necessary skills in a targeted manner. Your projects stay on schedule and budget.
With the final certificate, you can prove your skills and increase your market value.
At the same time, companies meet the ISO 13485 requirements for training.
The workshop covers the following topics:
After the workshop, you will:
The workshop is aimed at software developers working for medical device and IVD medical device manufacturers who:
The workshop is aimed specifically at software developers working for medical device and IVD medical device manufacturers. It builds on their experience, goes down to the code level, and uses the language and terminology of programmers.
This workshop is only offered in-house, as it is specifically tailored to your programming language and platform.
To receive a quote and arrange a date, please send an e-mail to [email protected]. We will get in touch with you as soon as possible.
The workshop is only offered as an in-house event, either at your premises or as an online seminar via web conference. The maximum number of participants is 15.
If you experience technical problems while participating online 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.
Our general FAQ section answers further technical and organizational questions.
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.
The software experts who will guide you through the workshop from day 3 to 6 will be selected flexibly depending on the programming language you work with.
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