Qualify and classify your software in minutes.
Assessment of MD or non-MD qualification followed by determination of the associated class, based on your product description. An initial regulatory status is obtained in minutes, followed by an in-depth rationale.
A regulatory qualification that takes weeks.
Product teams developing healthcare software face the same entry-level question: does the MDR apply or not, and if so, which class? Finding the answer requires back-and-forth with experts, reading multiple texts, and drafting a rationale. Several weeks mobilized, at a time when the roadmap needs clarity.
A regulatory status in minutes.
From a product description, the tool applies MDR 2017/745 and IVDR 2017/746 rules to qualify your software and determine the associated class. The assessment is substantiated and traceable, ready to be discussed with stakeholders or filed in the dossier.
Product description input
You describe the medical function of the software, its target users, and the clinical context of use.
MD or non-MD qualification
The tool applies MDR 2017/745 and IVDR 2017/746 to determine whether your software qualifies as a medical device.
Class determination
Based on classification rules, the associated class is calculated: I, IIa, IIb, III for MDs, or A, B, C, D for IVDs.
Structured rationale
Each conclusion is backed by the rules invoked and their application to your case, ready to be filed in the regulatory dossier.
Reference document
The assessment report is delivered in an exportable format, ready to be filed in the regulatory dossier or shared with stakeholders.
