[Translate to English:] Klinische Bewertung

Clinical Evaluation Starter-Kit

Your step-by-step guide to MDR-compliant clinical evaluations for medical devices and IVDs

 

Start immediately & save time

You will receive practical templates and checklists that enable you to start working immediately – without time-consuming research.

 

Gain security

Take advantage of our extensive experience to ensure that your approach complies with MDR regulations.

 

Reduce costs

You will require less external advice. However, should you still need support, we are at your disposal.

 

The free Clinical Evaluation Starter-Kit includes the following:

1. Guide to the most important steps

You will receive a clear roadmap from planning to the finished Clinical Evaluation Report.

 

2. Tools & Resource Planning

  • Recommendations for literature research tools (Elicit, Chat-PDF)
  • Post-market radar for continuous monitoring
  • Realistic time planning for your team
[Translate to English:] Mann und Frau analysieren Dokumente
[Translate to English:] Team analysiert gemeinsam Dokumente im Büro

3. Key documents & interfaces

  • Overview of all required documents with deadlines
  • Checklists for CER, CEP and PMCF plan
  • Interfaces to risk management and post-market surveillance

4. Practical tips for notified bodies

Benefit from insider knowledge gained from years of experience for successful communication with notified bodies.

 

5. Overview of recommended training courses

From beginner seminars to the guided clinical evaluator, we offer the right training and education programmes in the field of clinical evaluation for every application.

 

Request your free Clinical Evaluation Starter-Kit

Do you require additional support for your clinical evaluation?

Our team of experts will assist you with all further steps.

 

Get in touch, we're happy to help!
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+49 7531 94500 20

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Feedback of our Customers

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HeVaTech GmbH has been working with the Johner Institute for several years. Together, we have created the CER and all technical documen­tation for our medical devices. Mr. Bethäußer provided us with expert and timely support in classifying and creating the TD. We would like to express our sincere thanks for this. We would also like to thank Ms. Wettlaufer and Ms. Penn for their expert support in creating the CER. We can recommend the Johner Institute as a consulting partner to any medical device manufacturer!
Sigmar Hengge, HeVaTech GmbH
The starter kit provided exactly the guidance we needed. We had our clinical evaluation plan ready in two weeks!
Dr. Sarah M., Regulatory Affairs Manager
We always receive very quick and competent feedback from the Johner Institute. The offers are individually tailored to our problems and we can rely 100% on the work and statements we receive from the Johner Institute. We are glad to be able to request such support!
Alexa Tulaszewski, Telos GmbH
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FAQs about the Clinical Evaluation Starter-Kit

Is the Starter-Kit really free?

Yes, 100% free of charge and without obligation.

For which medical device classes is it suitable?

The starter kit is relevant for all medical device classes, with a special focus on classes IIa and IIb.

How up-to-date is the information?

As of February 2025, regularly updated in accordance with MDR changes.

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