QMS

This medical device quality management software is designed to consolidate data, enhance design controls, and ensure compliance with ISO 13485 and FDA 21 CFR 820 standards. It simplifies audits, reduces risks, and keeps you inspection-ready by automating critical quality workflows.

The software offers comprehensive features such as document control, training, and event management, all within a compliant and structured framework. It supports design documentation management with clear workflows, oversight, and traceable records, backed by audit trails and e-signatures compliant with 21 CFR Part 11.

Users can generate audit-ready reports instantly for internal reviews, external partners, or regulatory submissions, directly from their project workspace. The software also facilitates easy management of traceability, allowing users to view, add, update, or remove design controls and verification or validation runs seamlessly.

Included are ready-to-use report templates based on industry best practices, eliminating the need for manual design or configuration. The software is trusted by leading medical device organizations and offers a complete feature set to streamline compliance and design control documentation.

Key Features:

• Document Control: Automate document creation, approval, and management with audit trails and permission settings.
• Design and Development: Intuitive workflows, traceability matrix, and version comparison tools streamline the design process.
• Training and Competence: Role-based training linked to document updates ensures audit readiness.
• Quality Events and CAPAs: Real-time capture of deviations, complaints, and events with thorough documentation and corrective actions.
• Change Control and Supplier Management: Manage change requests and supplier qualifications securely.

The software helps medical device innovators reduce time-to-market by up to 35% and lower compliance costs by up to 50%. It is available in flexible packages, from a free version with basic features to comprehensive solutions with advanced capabilities like audits, supplier management, and risk assessment.