Clinical evaluations for medical software – when safety is not an add-on!

Software used in a medical setting is more than just a technical tool. It not only supplies medically relevant data but also supports decision-making, structures therapeutic processes, and enables the identification of potential risks at an early stage.

And although qualitative differences regarding the medical purpose for which particular medical software is used exist, the same regulatory standards apply to it as to traditional medical devices—with good reason.

The requirements? Challenging.
The leeway? Must be utilized.
The expectations? Clearly defined.

TentaConsult Pharma & Med GmbH has been supporting companies in the clinical evaluation of their medical devices for many years—and also offers this service for medical device software, with a clear focus on the essentials and a profound understanding of what really counts from a regulatory perspective.

Regulation needs relevance—not text modules!

The focus is on a thoughtful analysis of the intended medical device software functions and their impact on the classification—ultimately leading to the development of a robust clinical evaluation strategy (such as the WET or equivalence route). Whether based on own study data, relevant literature data, or equivalence assumptions—TentaConsult carries out the entire process up to the preparation of a clinical evaluation report. By leveraging our long-term experience, we support you at every stage of the process to fulfil regulatory requirements and meet notified body expectations concerning the quality of a clinical evaluation for medical device software.

As with any other medical device, the clinical evaluation of medical device software is not a tedious compulsory exercise but constitutes the basis for concluding that the medical device is suitable for its intended purpose, performs adequately, and is safe. In contrast to other medical devices, medical device software often involves a higher level of complexity, posing novel challenges to manufacturers.
But when is technical data sufficient—and when is meaningful clinical data required to ensure patient safety? Is quantitative data needed, or is a qualitative description sufficient?

TentaConsult Pharma & Med GmbH is a reliable partner for manufacturers—with expertise, methodological comprehension, and a trained eye for regulatory pitfalls. If desired, we can also take over communication with your notified body, "translate" the regulatory requirements, and navigate you through this jungle, which is often barely penetrable for medical device software developers.

More information and a first non-binding exchange:
www.tentaconsult.com or directly via info@tentaconsult.com

About TentaConsult Pharma & Med GmbH
TentaConsult, based in Münster, is a consulting company specialized in the life sciences sector. The company offers regulatory consulting, services in quality assurance, and assumes responsibility for medicinal products, medical devices, combination products, food supplements, and cosmetics.
As part of the Tentamus Group, TentaConsult works closely with international laboratories and partner companies throughout the entire product development and authorisation process.