With our workshops, we aim to offer individual solutions tailored to your questions, your company and your medical device(s), which not only provide you with theoretical knowledge, but also provide you with practical solutions to the regulatory challenges .

With our seminars we offer you a deep insight into our wealth of experience in the respective areas.

We offer tailor-made workshops and seminars for you and your company on site or online. Depending on the topic and/or intensity, either half-day or full-day.

Here is a selection of topics that we currently offer as workshop or seminar formats:

Measurable parameters in Clinical Evaluation Plans (CEP) and Clinical Evaluation Reports (CER)

In the approval process for medical devices, many companies repeatedly stumble over the same obstacle: the correct handling of measurable parameters in Clinical Evaluation Plans (CEP) and Clinical Evaluation Reports (CER). The Notified Bodies demand precise, measurable and substantiated claims.

Objective of the workshop:

This interactive workshop aims to provide participants with the knowledge and tools necessary to:

  • Identify measurable parameters for your product: Learn which measurable parameters are crucial for the approval of your medical device and how you can effectively highlight them in your documentation.

  • Develop effective and precise formulations: Develop strategies to formulate your claims clearly, precisely and convincingly.

  • Perform a correct assessment: Understand the methods and processes necessary to correctly assess and interpret your data.

  • carry out a successful substantiation: Find out how to substantiate your claims with solid data and evidence and thus meet the requirements of the Notified Bodies.

Who is this workshop suitable for?

This workshop is specifically designed for professionals from the medical device industry who are directly or indirectly involved in the approval and clinical evaluation of medical devices.

The workshop is also of interest to managing directors and decision-makers within start-ups and established companies in the field of medical devices. They can gain a deeper understanding of regulatory requirements, which improves strategic planning and time to market for their products.

The role of the sponsor in clinical trials
Understanding and implementing the role of the PRRC in the medical device industry
Quality management for medical devices in accordance with ISO 13485 and MDR
Literature search for clinical evaluation

Carefully conducting a literature search is a critical step in the clinical evaluation of medical devices that forms the basis for an informed assessment of your device's safety and performance. This workshop serves as a practice-oriented addition to our e-learning offering and focuses on specific exercises and techniques tailored to your product. Experience interactive practical exercises that not only give you the necessary knowledge, but also enable practical application.

Workshop participants will learn:

  • Efficient literature search strategies: Develop skills to efficiently and specifically search for relevant literature for the clinical evaluation of your product.

  • Evaluation and selection of literature: Learn how to evaluate and select the literature found and determine its relevance to the clinical evaluation of your product.

  • Practical application to your product: Conduct literature searches using real-world examples specific to your product to immediately apply the techniques learned.

  • Documentation and Reporting: Understand how literature search results are documented and integrated into the clinical assessment report to meet regulatory requirements.

Who is this workshop suitable for?

This workshop is ideal for anyone working in the regulatory affairs or clinical affairs area of ​​medical devices.

Regulatory updating and gap analysis to maintain technical documentation compliance
Digitalization in healthcare – opportunities, risks and strategies for providers
Digital health applications (DiGA) – education and use for patients and doctors

This is just a small selection of topics for which we offer workshop formats or seminars. If you are interested in a workshop or seminar, please contact us using the contact form to receive an offer tailored to your needs.

You can also send a request by email: info (at)

medXteam GmbH

Hetzelgalerie 2 67433 Neustadt / Weinstraße
+49 (06321) 91 64 0 00
kontakt (at)