Medical Device Registration
Expedite Your Medical Device Registration with Confidence
We at Aequum can simplify the process of registering medical devices in the EU, ensuring your products meet the necessary regulatory requirements under the MDR and IVDR. Our team is well-versed in the nuances of the regulatory landscape, enabling us to guide manufacturers through the classification, technical documentation preparation, and conformity assessments required for successful registration.
Our hands-on approach means we handle everything—from initial classification of your product to final submissions, including any necessary interactions with EU regulatory bodies. We make sure your product is compliant and ready for market distribution in the shortest possible time.
Our Medical Device Registration Services Include:
Comprehensive regulatory pathway assessment
Preparation and submission of technical documentation
Conformity assessments and CE marking
