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Average Ratings 858 Ratings

Description

Our robust platform enables real-time de-identification, allowing for the swift sharing and examination of imaging, physicians' notes, device information, medical records, laboratory results, and more. The concept of reinventing access involves a complete overhaul of the traditional model. Instead of removing data from the system, we create an invitation for med-tech and life sciences organizations to engage within the secure, dedicated environment of healthcare providers. We equip scientists with the necessary tools to scrutinize the data, ensuring that healthcare providers retain ultimate authority. By fostering a collaborative network that includes academic healthcare institutions, community health centers, specialized practices, med-tech firms, pharmaceutical companies, and researchers, we are driving innovation forward. This collaboration enhances the benefits for all involved, while reinforcing a commitment to security and privacy. Throughout this process, healthcare providers have absolute control over who accesses their data at all times, ensuring transparency and trust in every interaction. Moreover, this approach not only streamlines operations but also cultivates a culture of continuous improvement and shared knowledge.

Description

Qualio is a purpose-built quality and compliance platform for life sciences companies operating in complex, high-stakes regulatory environments. Medical device, SaMD, biotech, and pharma teams use Qualio to replace fragmented eQMS tools, spreadsheets, and consultant-driven audits with a single, validated system that delivers continuous audit and inspection readiness. Qualio combines a modern eQMS with Compliance Intelligence—an AI-driven layer that continuously evaluates how well real operating data aligns with regulatory requirements. Instead of treating audits as one-off events, teams gain always-on visibility into compliance coverage, risk exposure, and readiness across FDA, ISO, EU MDR, GxP, and software-intensive standards. Core quality workflows—document control, training, CAPA, change management, supplier quality, and design controls—are directly connected to regulatory obligations and objective evidence. Deep integrations with Jira, Azure DevOps, GitHub, TestRail, and Salesforce automatically capture proof from development and operational systems, eliminating manual evidence gathering and reducing compliance drag on engineering teams. Compliance Intelligence runs multi-standard gap analysis in under an hour, flags emerging risks before they become findings or 483s, and maps reusable evidence across frameworks to accelerate submissions and market expansion. All insights are explainable and traceable back to specific clauses and internal policies, supporting validation and audit expectations. The result: audit readiness in weeks instead of months, fewer fire drills, faster launches, and lower long-term compliance cost. Qualio turns compliance from a reactive burden into a predictable, scalable system.

API Access

Has API

API Access

Has API

Screenshots View All

Screenshots View All

Integrations

Asana
Azure AI Document Intelligence
Azure DevOps
ComplianceWire
Dynamics 365 Customer Service
GitHub
GitHub Advanced Security
GitLab
GitLab Duo
HubSpot CRM
Jira
Microsoft 365
Microsoft Dynamics 365
Microsoft OneDrive
Okta
Salesforce
TestRail
Xray
Zendesk
Zephyr

Integrations

Asana
Azure AI Document Intelligence
Azure DevOps
ComplianceWire
Dynamics 365 Customer Service
GitHub
GitHub Advanced Security
GitLab
GitLab Duo
HubSpot CRM
Jira
Microsoft 365
Microsoft Dynamics 365
Microsoft OneDrive
Okta
Salesforce
TestRail
Xray
Zendesk
Zephyr

Pricing Details

No price information available.
Free Trial
Free Version

Pricing Details

No price information available.
Free Trial
Free Version

Deployment

Web-Based
On-Premises
iPhone App
iPad App
Android App
Windows
Mac
Linux
Chromebook

Deployment

Web-Based
On-Premises
iPhone App
iPad App
Android App
Windows
Mac
Linux
Chromebook

Customer Support

Business Hours
Live Rep (24/7)
Online Support

Customer Support

Business Hours
Live Rep (24/7)
Online Support

Types of Training

Training Docs
Webinars
Live Training (Online)
In Person

Types of Training

Training Docs
Webinars
Live Training (Online)
In Person

Vendor Details

Company Name

Lynx.MD

Founded

2018

Country

Israel

Website

www.lynx.md/

Vendor Details

Company Name

Qualio

Founded

2010

Country

United States

Website

www.qualio.com

Product Features

Product 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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