Our expert team specialises in creating these files, ensuring strict adherence to regulations like EU MDR, IVDR, and FDA requirements.

Our consultancy excels in evaluating and appraising relevant scientific literature, providing essential evidence on the state of the art of treatment.

Our proficiency extends to drafting clinical evaluations to substantiate sufficient clinical evidence, or if additional clinical evidence is required.

Our expertise covers support for creation of performance evaluations that encompass analytical, scientific, and clinical dimensions. We meticulously compile data, ensuring the coherent integration of each section.

We will compile and refine the finalised FDA submission in Electronic Common Technical Document (eCTD) format, to meet the exacting standards set by the FDA.

By preparing a MDL application for Canada and drafting summaries, manufacturers can significantly improve their chances of successfully approvals for their devices.