MediNova

EU MDR FDA

MediNova is an Australian medical-device and SaMD consultancy providing regulatory pathway analysis, submission planning and lifecycle compliance support. Its work covers TGA, FDA, EU MDR and UKCA routes, including classification, standards mapping, gap assessments and technical-documentation review. The firm also supports quality systems, risk management, post-market activities and audit preparation.

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Free MDR Templates

Dr. Oliver Eidel

103 views · over 2 years ago

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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Getting Started

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

Updated 9 months ago

Dr. Oliver Eidel