Qualio

Overview

Qualio is a cloud-based quality management system (QMS) software company focused on supporting growing life science organizations, including those in the medical device, pharmaceutical, and biotech sectors. Its platform streamlines quality processes and accelerates time to market, helping companies achieve and maintain compliance with regulatory standards such as FDA QSR and ISO 13485.

The software offers a digital and collaborative environment for managing quality content and data, covering essential functions like document control, training, audits, and risk management. Qualio integrates with product design tools to automate compliance, making it especially beneficial for medical device companies. Serving over 650 life science businesses worldwide, the company emphasizes ease of use, rapid implementation, and flexibility through its fully remote team.

Basic Information

Contact Details

• Phone: +1 855-203-2010
• Website: qualio.com
• LinkedIn: linkedin.com/company/qualiohq
• Facebook: facebook.com/qualioqms
• AngelList: angel.co/qualio
• Twitter: twitter.com/qualiohq

Key Focus Areas & Initiatives

• Life science solutions
• Medical device compliance
• Pharmaceutical and biotechnology support
• Software as medical device (SaMD)
• Quality management and digital QMS
• Regulatory compliance (FDA, ISO)
• Risk and document control
• Training, audits, and validation
• Cloud-based quality automation
• Integration with product design processes
• Regulatory submission support
• Quality process improvement
• Continuous operational excellence
• Regulatory lifecycle and data integrity
• Supplier management and oversight
• Change management and product traceability
• Analytics and performance tracking
• Collaborative quality platform
• Audit readiness and management
• Quality training programs
• Digital transformation for life sciences

Technologies Used

• AI
• Amazon AWS
• BigID
• Create React App
• Digital Ocean Spaces
• Gmail
• Gong
• Google Apps
• Mailchimp Mandrill
• Mixpanel
• Rackspace MailGun
• React
• Recurly
• Remote
• Route 53
• Salesforce
• Segment.io
• Typeform

Affiliated Organizations & Regional Branches