Your customers experience the product. Your teams need the complete picture.
A unified approach to product quality, customer experience, and post-market vigilance.
Every product complaint, service request, repair, return, and enhancement opportunity carries valuable information about how a healthcare product performs in the real world.
Yet that information often remains fragmented across healthcare facilities, customer service teams, field service organizations, quality management systems, and regulatory functions.
Vigilia is building a unified platform to bring these activities together—helping life sciences organizations improve visibility, coordination, traceability, and post-market decision-making.
The Challenge
Product information is everywhere. The complete picture rarely is.
Healthcare products generate valuable information throughout their post-market lifecycle. But the teams responsible for managing that information often operate through separate processes and systems.
A product issue reported by a clinician may become a customer service inquiry, technical support request, complaint investigation, field service activity, regulatory assessment, or corrective action.
When these activities are disconnected, important context can be lost.
Fragmented intake
Product feedback and complaints arrive through emails, calls, customer portals, and internal systems.
Incomplete information
Missing product identifiers, event details, and supporting documentation can delay investigations.
Disconnected service activities
Returns, replacements, repairs, and technical support may be tracked separately from product quality records.
Limited cross-customer visibility
Similar issues across healthcare facilities can be difficult to identify and evaluate together.
Manual regulatory workflows
Documentation, coding, reportability assessments, and reporting activities require coordination across multiple teams.
Missed improvement opportunities
Enhancement requests and recurring customer challenges may not consistently reach the teams responsible for product improvements.
The challenge isn't simply collecting more data. It's connecting the information already being generated.
The Vigilia Approach
From fragmented interactions to actionable post-market intelligence.
Vigilia is designed to bring healthcare organizations and life sciences manufacturers together through structured, transparent, and traceable workflows.
Rather than treating each complaint, service request, return, or customer interaction as an isolated activity, Vigilia brings related information into a unified product history.
This approach aims to help teams maintain context across organizational boundaries, coordinate next steps, and identify opportunities for earlier intervention.
- Shared, not siloed.
- Connected, not fragmented.
- Structured, not informal.
- Visible, not buried.
- Proactive, not reactive.
Platform Capabilities
Built around the activities that shape product performance and safety.
01
Product Feedback & Complaint Management
Capture and organize product concerns, complaints, and supporting information through structured workflows connecting healthcare organizations with manufacturer teams.
Support more complete intake, clearer communication, investigation coordination, and traceability from initial report through resolution.
02
Service, Repair & Technical Support
Connect product-related service requests, field service activities, depot repairs, and technical support interactions with the broader product experience.
Improve coordination between customer-facing teams, service organizations, and quality functions while maintaining visibility into the status of product-related activities.
03
Product Returns & Replacements
Coordinate product returns and replacement requests while maintaining relevant information about the originating concern, product identification, and subsequent actions.
Help reduce fragmented communications between healthcare facilities, customer support, logistics, and manufacturer teams.
04
Post-Market Surveillance & Product Performance
Bring together product complaints, customer feedback, service information, and other relevant post-market data to support ongoing product performance monitoring.
Identify recurring issues, evaluate trends, and provide quality and post-market teams with more complete product information for investigation and risk assessment.
05
Regulatory Reporting & IMDRF Coding
Support regulatory workflows through structured documentation, traceable assessments, AI-assisted activities, and automated IMDRF coding capabilities.
Help quality and regulatory teams organize relevant information for reporting decisions and regulatory submissions while maintaining appropriate human review and oversight.
06
Enhancement Requests
Capture product enhancement requests from healthcare customers, clinical users, and service teams through structured workflows.
Help manufacturers collect, organize, evaluate, and track enhancement requests while maintaining visibility into customer needs, product usability, and requested functionality.
07
Recalls, Corrections & Removals
Support communication and coordination of product-related safety actions across manufacturers and healthcare organizations.
Improve visibility into affected products, customer communications, and follow-up activities to support more organized execution and tracking.
Vigi AI
Turn product information into actionable insights.
The value of post-market information grows when teams can recognize relationships across complaints, service activities, product performance, and customer experiences.
Vigi AI is being developed to help teams move from searching through fragmented records toward understanding the information connecting them.
Vigi AI is intended to support:
Information discovery
Access relevant product information and related records more efficiently.
Emerging trend identification
Highlight recurring product concerns, failure patterns, use errors, and potential product incompatibilities.
Investigation support
Bring relevant context together to assist quality and technical teams.
Coding and documentation assistance
Support structured classification and preparation of post-market information.
Timely escalation
Help teams recognize concerns that may warrant further review.
AI supports the process. Qualified professionals remain responsible for investigations, risk assessments, regulatory decisions, and required approvals.
Across the Product Lifecycle
One product issue. Multiple teams. Shared visibility.
A concern reported at a healthcare facility may involve several teams before it is fully understood and resolved.
Healthcare Professionals
Identify product concerns, performance issues, usability challenges, and opportunities for improvement.
Customer Support & Technical Service
Coordinate technical assistance, service, repairs, returns, and customer communications.
Product Quality & Engineering
Evaluate complaints, investigate product performance, assess recurring issues, and support corrective actions.
Regulatory Affairs & Post-Market Surveillance
Assess reporting requirements, monitor post-market information, and support regulatory obligations.
Leadership & Continuous Improvement
Gain a broader view of product-related activities, recurring challenges, and opportunities to strengthen product quality and customer experience.
Vigilia's approach is designed to maintain the connection between these activities rather than allowing each interaction to become another disconnected record.
The Value for Life Sciences
Better visibility. Stronger collaboration. More informed decisions.
For Quality & Regulatory Teams
More structured information, improved traceability, and greater visibility into product-related concerns and post-market activities.
For Customer Support & Service Teams
Clearer coordination of customer requests, technical support, repairs, returns, and related product issues.
For Product & Engineering Teams
Better access to customer feedback, recurring performance concerns, and opportunities for product improvement.
For Business & Operational Leadership
A unified view of customer experience, product performance, and operational activities that influence quality, efficiency, and customer confidence.
Our Direction
Strengthening existing systems by bridging the gaps between them.
Life sciences organizations already rely on established quality management systems, service platforms, regulatory processes, and enterprise applications.
Vigilia's vision is not simply to introduce another disconnected destination for product information.
It is to provide a unified experience across the interactions, workflows, and organizations involved in healthcare product safety and vigilance.
From the first product concern to investigation and resolution.
See Vigilia in Action
Better product vigilance starts with a conversation.
Discover how Vigilia is designed to support product complaints, service and repair activities, post-market surveillance, regulatory workflows, and customer collaboration.
Explore the platform, discuss your organization's priorities, and help shape the future of healthcare product safety.
No commitment required.