Medical Device Regulatory Specialist | CE Marking | ISO 13485 | FDA Compliance
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Qualio is a cloud-based eQMS (Electronic Quality Management System) designed for life sciences companies, including medical devices, pharmaceuticals, and biotech. It helps organizations manage compliance, document control, training, audits, CAPAs (Corrective and Preventive Actions), risk management, and regulatory submissions efficiently.
Key Features of Qualio:
✅ Document Control: Centralized system for version-controlled documents (SOPs, work instructions, policies).
✅ Training Management: Tracks employee training and ensures compliance.
✅ Audit & Compliance Support: Helps with FDA, ISO 13485, MDR, and other regulatory requirements.
✅ Risk Management: Integrates risk assessments and mitigations.
✅ CAPA & Change Control: Manages corrective actions and process changes.
✅ Collaboration & Traceability: Provides a single source of truth for teams working on quality and regulatory compliance.
Qualio is very easy to use and allows you to access your training as well as stay compliant with secure Single Sign-On (SSO) one less password to remember. It’s a great tool for managing quality documents too.
Qualio is a cloud-based quality management software system designed for life science companies.
Qualio empowers medical device, pharmaceutical, biotech, and contract organizations to get to market faster, boost revenue, and cut risk. Over 500 companies in 80 countries use Qualio to embed and automate GxP, FDA, and ISO compliance. Qualio unites your teams, processes, and data in a single source of truth that supports a culture of quality and makes your business stronger, fitter, and more competitive.
Qualio is a comprehensive electronic quality management system (eQMS) purpose-built for life science companies developing and marketing life-saving products. Qualio integrates your teams, tools and da
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