Quality Software for Medical Devices Archivi

Software Medical Devices

Quality Software for Medical Devices

Quarta EVO QMS (Quality Management System)

Ensures compliance with regulatory standards and GMP, while monitoring the conformity of approval processes such as Claims, Deviations, CAPA, Change Requests, and SOPs, in addition to the Control and Release of finished products.

In the Medical Device sector, Quality Management is not just a legal obligation but a necessity to guarantee the safety and effectiveness of medical devices. Companies that invest in Quality Management not only protect patients but also safeguard their long-term competitiveness in the global market.

A Quality Software for Medical Devices is not only a regulatory requirement but also a strategic tool to improve product quality, business efficiency, and stakeholder trust. Its benefits extend across the entire value chain, making the Quality Management System a cornerstone for sustainable success.

Quarta EVO supports the Medical Device industry in producing safe, reliable, profitable, and compliant products on time, with a range of dedicated features, such as:

Incoming and in-process inspections to ensure product release in compliance with GMP
Complete tracking of Deviations in different contexts and their related CAPA
Documentation management, particularly SOPs, with approval workflows and document sharing
Logbook of scheduled maintenance for company assets

Why choose Quarta EVO if you're a Medical Devices company

Regulatory Compliance: Quarta EVO QMS is designed to help ensure compliance with industry standards such as FDA 21 CFR, ISO 13485, and others.
Safety and Reliability: Beyond Cyber Security, Quarta EVO guarantees safety and reliability through a robust authentication system that ensures each user has defined roles and permissions within the software. (This point could be included in the general Quarta EVO page since it applies across all sectors.)
Electronic Signature: Quarta EVO QMS includes electronic signatures for process advancement and records, ensuring full process traceability.
SOP & Documentation: Quarta EVO allows you to collect documentation in a digital company library and configure ad-hoc distribution lists for each document.
Deviations & CAPA: Quarta EVO QMS manages Deviations and related CAPA through a Workflow engine that involves all stakeholders, progress tracking, and communication between departments.
Change Request: Quarta EVO structures the technical change request process, enabling contributions from all involved colleagues and ensuring that the latest version of product technical drawings is distributed across all workstations, reducing the margin of error.
Supplier Management: Quality starts with suppliers. That’s why Quarta EVO QMS provides comprehensive supplier management, from qualification and sampling to final monitoring with Vendor Rating.