Claims and their Validation in Clinical Evaluation – Inhouse Training

What are claims, and how can I substantiate them?

In the context of the MDR, “claims” refer to statements or assertions made by manufacturers regarding the intended use, performance, or benefits of a medical device.

These assertions can cover a wide range of aspects related to the product, including its intended purpose, indications for use, effectiveness, safety, and any other characteristics that may be relevant to the product’s performance or benefits. Claims relevant to the clinical evaluation can be found inthe technical documentation, but also frequently in marketing materials and similar documents.

The MDR, as well as the FDA for example, require that every claim be objectively substantiated, such as through clinical data. Substantiating such claims often presents a challenge that should not be underestimated.

In our three-hour seminar, we delve into the various aspects of claim evaluation. In addition to theoretical foundations, we offer you practical approaches and tools to formulate, review, and substantiate claims confidently and efficiently. Together, we will explore the following questions, among others:

• What are claims, and how can they be effectively categorized?
• Where can claims be found, and how can they beidentified?
• What methods are available for substantiating claims?
• What are the key considerations when formulating claims?

This training offers you the opportunity to clarify your questions and discuss specific challenges from your professional practice. Benefit from practical tips and an in-depth exchange with our speaker and other participants.