Beginners' Seminar "Clinical Evaluation"

The seminar covers the following topics: 

• Regulatory basis according to MDR 
• Overview of different data routes (clinical data on your own device and equivalence data, performance data) 
• Interface to key processes such as development, risk management, or PMS 
• Requirements for author qualifications 
• Costs and expenses of a clinical strategy 
• Components of a clinical evaluation file

After the seminar, you will have all the relevant information to: 

• check and assess the qualifications of the service provider's authors based on reliable criteria. 
• understand whether the calculation of the service provider you want to commission to write a clinical evaluation is complete. 
• check whether a clinical evaluation you have commissioned from a service provider is complete and of good quality. 
• ensure that you can sign a clinical evaluation in good conscience.

This seminar is designed for people who: 

• delegate the writing of clinical evaluations to service providers or internal departments and, therefore, must check that the quality and scope are appropriate. 
• work in regulatory affairs or quality management and are responsible for approving documents and co-signing clinical evaluations. 
• need a solid basic understanding and important tips and background information, even if they do not (yet) write clinical evaluations themselves. 
• need to assess the quality of clinical evaluations and review offers from service providers.

Participants can easily follow this seminar even without any special prior knowledge. Understanding your 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 [email protected] to find a solution.  

Three days before our online seminars and workshops, 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.   

If the seminar or workshop takes place in person, you will also receive the access link to your seminar documents three days before the date of the event. We will also provide documents in digital form for in-person events. 

The seminar takes place either in person or online.  

Our online/remote seminars and workshops 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. 

We also recommend that you arrive at the seminar room approximately 20 minutes before the start of the face-to-face events.

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. 

Our general FAQ section answers further technical and organizational questions.