EU MDR 2017/745 Compliance Checker
The EU Medical Device Regulation (MDR) 2017/745 establishes a comprehensive regulatory framework for medical devices placed on the European market, including Software as a Medical Device (SaMD). This tool evaluates your quality management system, clinical evaluation processes, technical documentation, post-market surveillance, and Unique Device Identification (UDI) registration to determine your readiness for CE marking and notified body assessment.
Progress: 0/22
Quality Management System
0/5Clinical Evaluation
0/5Technical Documentation
0/5Post-Market Surveillance
0/5UDI & Registration
0/2Quality Management System
Evaluation of your QMS and its alignment with EU MDR and ISO 13485 requirements.
Q1
Do you have a Quality Management System (QMS) certified to ISO 13485:2016 that covers the entire lifecycle of your medical device, including design, development, production, and post-market activities?
Q2
Have you implemented a risk management process compliant with ISO 14971, covering hazard identification, risk estimation, risk evaluation, and risk control throughout the device lifecycle?
Q3
If your product is Software as a Medical Device (SaMD), have you classified it according to MDR Annex VIII Rule 11 and validated it using IEC 62304 software lifecycle processes?
Q4
Do you have a documented design and development process with defined design inputs, outputs, verification, and validation activities, including traceability to user needs and regulatory requirements?
Q5
Do you conduct management reviews of your QMS at planned intervals (at least annually) that include analysis of post-market data, CAPA effectiveness, and regulatory changes?
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