RegCompl.AI digitalizes and automates the certification process for medical devices and software as a medical device with the help of AI.

We guide you through standards, regulations, and processes – so that your innovations get where they are needed most: The Patient. All it takes is four simple modules:

1 • Feasibility Check

Automated Feasibility Check

We automatically analyze the preliminary documents submitted to any notified body. Among other things, we check the intended use, the risk classification of the product, and the planned conformity assessment procedure for plausibility and regulatory compliance.

2 • AI Gap-Analysis

Automated Pre-check of Documentation

The submitted documents are automatically evaluated for completeness and receive a quality assessment. Manufacturers get real-time feedback on identified gaps or deviations from regulatory requirements—especially with regard to the European Medical Device Regulation (MDR).

3 • Intelligent Co-Pilot

Virtual Assistance for all Project Participants

A digital assistance system supports project managers, clinical experts, and auditors in their tasks—for example, through automated comparison with normative requirements (e.g., ISO 13485, ISO 14971, IEC 62304) and context-related recommendations.

4 • Certification of Final Documentation

Automated Drafting of the EU Declaration of Conformity

Based on the recorded and verified data, the draft Declaration of Conformity is automatically generated and made available to the manufacturer as a template – compliant with standards and in the correct format.

Regulation on your Mind?

Certification Re-imagined