Do you use AI systems in your day-to-day work, but do not place them on the market as part of your own medical device or IVD? Find out what obligations you must fulfil as a user or deployer under the EU AI Act, how to validate your AI tools in a regulated environment in accordance with ISO 13485 using a risk-based approach, and how to safely integrate their use into your quality management system
This seminar is aimed at AI users (deployers): anyone who uses AI in their day-to-day work without placing it on the market as part of their own medical device or IVD – for example, in laboratories, hospitals and medical technology companies. You will learn when you are considered a user or deployer under the AI Act, how to identify high-risk AI, and how to translate these obligations into the processes, documentation and roles within your QMS.
In addition, you will receive practical guidance on how to validate AI systems on a risk-based approach within the framework of Computer System Validation (CSV), and how to build and demonstrate AI literacy within your organisation.
Are you developing AI-based medical devices or IVDs? If so, our seminar ‘Regulatory Requirements for AI-Based Medical Devices – Practical Implementation of the MDR/IVDR & AI Act’ is the right choice for you.
The AI Act distinguishes between those who develop and place AI systems on the market (providers – in the case of medical devices, this means the manufacturers) and those who use them (operators or deployers). This seminar is aimed at the latter: anyone who uses AI in their day-to-day work without placing it on the market as part of their own medical device or IVD. You will learn when you are considered a deployer, what obligations this entails for you – particularly in the case of high-risk AI systems – and what changes when using everyday tools such as LLMs. Even where there is no specific legal obligation, the following applies: anyone who uses AI without a strategy risks inefficiency, poorer results and the loss of intellectual property.
This seminar is new; that’s why there aren’t any reviews here yet. If you’d like to find out what participants have to say about other courses run by our tutor, please do take a look here.
You will learn how to integrate the use of AI into your quality management system in a structured way – covering role definitions, standard operating procedures (SOPs), training, documentation, monitoring and reporting channels. This will enable you to translate regulatory requirements into practical processes for your organisation. In addition, you will receive practical guidance on the risk-based assessment and validation of AI systems within the framework of Computer System Validation (CSV). This will help you to manage AI applications appropriately, even independently of the AI Act.
This seminar is specifically aimed at users of AI systems in the medtech, IVD, laboratory and healthcare sectors. The focus is not only on the text of the legislation, but also on what the requirements actually mean for your quality management system, your processes and your responsibilities. You will benefit from the combination of our AI-Act know-how and our regulatory expertise in regulated sectors. This will provide you with an understanding tailored to the day-to-day practices of manufacturers, laboratories and clinics.
The EU AI Act requires organisations to take measures to promote AI literacy amongst their staff (Art. 4). You will learn what this means in practical terms for your organisation and how to identify and document training needs effectively. We will also clarify whether you need an AI officer: the AI Act does not mandate such a role.
At the end of the seminar, you can take a voluntary online exam (duration: approx. 20 mins). If you pass this exam, you will receive a certificate in addition to your certificate of attendance. This certifies the knowledge you have acquired during the seminar and helps you to demonstrate the measures you have taken to promote AI literacy in accordance with Article 4 of the AI Act.
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In this seminar, you will learn what requirements the EU AI Act actually imposes on users of AI systems and how to implement them in a practical manner within regulated environments:
By attending the seminar, participants will achieve the following objectives:
This seminar is designed for anyone who uses AI systems in the medical device and IVD sectors.
These include, for example, individuals in the following roles
Do you develop AI-based medical devices or IVDs yourself? If so, our seminar for manufacturers is the right choice for you.
No specific prior knowledge is required. A basic understanding of your internal processes (e.g. QM/SOP structure, IT approval processes, data protection and information security requirements) is helpful, so that you can quickly apply the content to your day-to-day work.
Once you have registered, you will receive a confirmation email containing the meeting link, the time and information about the participants.
Within the next 48 hours, you will be sent an invoice with a payment term of 14 days. If this payment term is not feasible for your organisation, please send a brief email to [email protected] so that we can find a solution.
Three days before the seminar, you will receive two emails: the first contains the final link to the seminar and the second includes the access details for a cloud folder where you will find preparatory materials, exercises and presentations.
Our online/remote seminars are conducted via the MS Teams video conferencing tool. We recommend that you log in 20 minutes before the seminar begins to resolve any technical issues in good time. Our team is available at any time should you have any questions or encounter any problems.
At the end of the seminar, you will receive a feedback link to complete an evaluation. We will send you your certificate of attendance the following day.
Should you encounter any technical difficulties whilst taking part, or if you have any other questions, you can contact our support team at short notice at any time. The documents provided also include an emergency number to assist you in urgent cases.
Further technical and organisational questions are answered in our general FAQ.
M.Eng. Anja Bentz completed a dual degree in electrical engineering following her training as a biological-technical assistant, followed by a Master’s degree in medical technology specialising in artificial intelligence in medicine. Her expertise lies in standards-compliant software development and consultancy relating to the AI Act. Her interdisciplinary expertise enables her to provide clients with a wide range of support. Her aim is to act as a reliable partner in tackling regulatory challenges.
We are happy to offer our seminars, courses and workshops on-site as well. Depending on your requirements, these can be held either online or at your premises.
Please feel free to get in touch.
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