Medixion

EU MDR Clinical Evaluation

Medixion is a small medical device consultancy based in Leiden, the Netherlands. Its team combines clinical practice and biomedical engineering to guide products from concept toward market launch under the EU MDR. Consulting covers intended purpose and classification, risk analysis, design verification and validation, clinical evaluation and trials, and technical documentation. The firm also offers medical-device design and prototyping support for clinically oriented development projects.

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Dr. Oliver Eidel

103 views · over 2 years ago

Getting Started

EU MDR: Step-By-Step Guide To Becoming Compliant

Updated 9 months ago

Dr. Oliver Eidel

SaMD : Is the frontend part of the medicla device under EU MDR ?

Anonymous

8 months ago

In a CE-marked SaMD under EU MDR, only the backend of our software performs the medical function (clinical data processing, rule evaluation, alert generation). The frontend performs no medical logic a

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