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What is Qualio?

Qualio is a unified quality and compliance platform that helps growing life sciences companies scale faster while staying continuously audit- and inspection-ready. Medical device, digital health, biotech, and pharma teams use Qualio to replace manual processes and disconnected tools with a single source of truth for quality, regulatory readiness, and risk. With a modern eQMS at the foundation and Compliance Intelligence layered on top, Qualio moves teams beyond point-in-time audits. Automated gap analysis, cross-standard evidence mapping, and real-time readiness dashboards provide confidence that the organization is prepared today—not just when auditors arrive. Qualio centralizes document control, training, CAPA, change management, supplier quality, and design controls, linking them directly to regulatory requirements and product lifecycle data. Executive-ready views show compliance health by standard, region, and product, turning regulatory readiness into a measurable business capability instead of a black box. Compliance Intelligence continuously monitors for risk, highlights gaps early, and prioritizes remediation so teams focus effort where it matters most. Pre-validated regulatory frameworks are maintained as requirements evolve, reducing reliance on consultants and avoiding duplicate work as companies expand. The result is faster market entry, lower compliance cost, reduced risk of findings or recalls, and confident, risk-managed growth.

What is Lynx.MD?

Our advanced platform facilitates real-time de-identification, enabling rapid sharing and analysis of various types of data, including imaging, physician notes, device details, medical records, and laboratory findings. This initiative to transform access signifies a fundamental change from conventional models. Rather than extracting data from the system, we create a welcoming environment for med-tech and life sciences organizations to collaborate securely with healthcare providers. We empower scientists with essential tools to analyze the data, while healthcare providers maintain complete control. By establishing a cooperative network that encompasses academic healthcare institutions, community health centers, specialized practices, med-tech companies, pharmaceutical organizations, and researchers, we are propelling innovation forward. This partnership not only maximizes benefits for all parties involved but also reinforces our dedication to security and privacy. Throughout this journey, healthcare providers retain full authority over data access, promoting transparency and trust in every interaction. Additionally, this strategy not only optimizes operational efficiency but also fosters a culture of ongoing enhancement and collective knowledge sharing among all stakeholders. Ultimately, our vision is to create a more interconnected healthcare ecosystem that thrives on collaboration and innovation.

Media

Media

Integrations Supported

Asana
Azure AI Anomaly Detector
Azure DevOps Labs
Azure DevOps Server
Azure-AD-External-Identities
Dynamics 365 Customer Service
GitHub
GitHub Advanced Security
GitLab Duo
Google Cloud Operations Suite
HubSpot CRM
Microsoft 365
Microsoft Dynamics 365
Microsoft OneDrive
RegDesk
Salesforce
TestRail
Xray
Zendesk
Zephyr

Integrations Supported

Asana
Azure AI Anomaly Detector
Azure DevOps Labs
Azure DevOps Server
Azure-AD-External-Identities
Dynamics 365 Customer Service
GitHub
GitHub Advanced Security
GitLab Duo
Google Cloud Operations Suite
HubSpot CRM
Microsoft 365
Microsoft Dynamics 365
Microsoft OneDrive
RegDesk
Salesforce
TestRail
Xray
Zendesk
Zephyr

API Availability

Has API

API Availability

Has API

Pricing Information

Pricing not provided.
Free Trial Offered?
Free Version

Pricing Information

Pricing not provided.
Free Trial Offered?
Free Version

Supported Platforms

SaaS
Android
iPhone
iPad
Windows
Mac
On-Prem
Chromebook
Linux

Supported Platforms

SaaS
Android
iPhone
iPad
Windows
Mac
On-Prem
Chromebook
Linux

Customer Service / Support

Standard Support
24 Hour Support
Web-Based Support

Customer Service / Support

Standard Support
24 Hour Support
Web-Based Support

Training Options

Documentation Hub
Webinars
Online Training
On-Site Training

Training Options

Documentation Hub
Webinars
Online Training
On-Site Training

Company Facts

Organization Name

Qualio

Date Founded

2010

Company Location

United States

Company Website

www.qualio.com

Company Facts

Organization Name

Lynx.MD

Date Founded

2018

Company Location

Israel

Company Website

www.lynx.md/

Categories and Features

Compliance

Archiving & Retention
Artificial Intelligence (AI)
Audit Management
Compliance Tracking
Controls Testing
Environmental Compliance
FDA Compliance
HIPAA Compliance
ISO Compliance
Incident Management
OSHA Compliance
Risk Management
Sarbanes-Oxley Compliance
Surveys & Feedback
Version Control
Workflow / Process Automation

Policy Management

Approval Process Control
Attestation
Audit Trails
Policy Creation
Policy Library
Policy Metadata Management
Policy Training
Reporting / Analytics
Version Control
Workflow Management

Quality Management

Audit Management
Complaint Management
Compliance Management
Corrective and Preventive Actions (CAPA)
Defect Tracking
Document Control
Equipment Management
ISO Standards Management
Maintenance Management
Risk Management
Supplier Quality Control
Training Management

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