CE and UKCA Marking Compliance Software

The CE and UKCA Marking Compliance Software is designed to assist medical device and in vitro medical device companies in achieving and maintaining compliance with EU MDR/IVDR and UK MDR requirements. This software addresses the challenges posed by complex and evolving legislation, as well as the impacts of Brexit, which have complicated market entry into the EU and UK.

Qualio's integrated eQMS software provides a comprehensive solution for ensuring long-term compliance. It features automatic, AI-powered gap analysis that scans your Quality Management System (QMS) in just 30-40 minutes, identifying compliance gaps with EU and MHRA standards. This allows organizations to allocate tasks efficiently and gather necessary device evidence, significantly reducing the time needed to become audit-ready.

The software fosters a collaborative, compliance-focused culture by serving as a cloud-based single source of truth. It aligns teams around version-controlled documents, training records, and workflow-driven digital processes, ensuring that CE and UKCA marks are achieved as a natural outcome rather than a stressful target.

Key Features:

• Automated gap analysis for quick identification of compliance gaps.
• Cloud-based platform for centralized, audit-trailed quality data.
• Support for design controls, management responsibility, clinical evaluation, and UDI.
• Compliance health dashboards for continuous monitoring.

Used by over 700 companies, this software ensures total EU and MHRA audit readiness, making it an essential tool for medical device companies aiming for a lasting presence in the European and British markets.