In this seminar, you will learn about the regulatory requirements for post-market surveillance (PMS) and how to implement them in your company without unnecessary effort. You will receive your first device-specific PMS plan, which you can use immediately and as a basis for future devices.
Our expert will first explain and place the general PMS process within the overall technical documentation process. It will give you a detailed understanding of the connections between all relevant areas. You will then learn about the basic requirements of the MDR and relevant MDCG documents for the PMS and the PMS plan. By the end, you will know exactly what you need to do in your company.
Very good overview of the topic; opportunity to discuss questions in depth; all necessary topics were covered in sufficient detail; concrete templates (SOP interfaces + PMS plan) are provided.
In the seminar, we will introduce you to various standards that will help you with the practical implementation. Using practical examples, you will learn how to handle different data sources for your PMS and efficiently search for and evaluate the relevant information. In addition, our expert will show you how to create a complete PMS plan that not only meets legal requirements but also delivers real added value.
In this seminar, you will actively work through most of the material in several sprints. You can immediately apply the outputs in your company: In addition to the seminar documents, you will receive our proven templates for the PMS plan and the standard operating procedure for the PMS process, which you can easily adapt to your company processes and devices.
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.
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+49 7531 94500 20
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The seminar covers the following topics:
• MDR requirements for post-market surveillance (PMS)
• The PMS process and relevant data sources throughout the product lifecycle
• Interfaces between PMS and quality management (QMS), risk management, and clinical evaluation
• Planning and preparation of PMS reports and PSURs, including trend reports and data classification
• Documentation and implementation of PMCF (Post-Market Clinical Follow-up) in accordance with current MDCG guidelines
After the seminar, you will
• Be able to understand and implement the MDR requirements for PMS and their practical application
• Design a complete PMS system, including interfaces to the QMS, risk management, and clinical evaluation
• Be able to create and document PMS and PMCF plans and reports in accordance with ISO TR 20416, MDR Annex III, and MDCG guidelines
• Be able to research, classify, and evaluate PMS data, as well as report trends in accordance with Article 88
• Organize PMCF studies and their documentation
• Systematically review PMS processes using a checklist
This seminar is designed for individuals who work in the following roles or aspire to do so:
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.
Dr. Nadine Jurrmann holds a doctorate in biology and worked for a medical device manufacturer for over six years. Her responsibilities at that time included conducting clinical evaluations and planning, implementing, and evaluating PMCF studies. Since 2019, she has been supporting our customers with strategic consulting on clinical evaluation and documentation of PMS and PMCF activities in accordance with MDR.
We are also happy to offer our seminars, courses, and workshops in-house. Depending on your needs, these can be held online or at your premises.
Please feel free to contact us.
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