2M+
medical device reports received by FDA each year
FDA report volume — not how issues move between healthcare and manufacturers, and not a Vigilia metric.
U.S. Food and Drug Administration
Advancing healthcare product safety and vigilance.
One platform. Across the healthcare product lifecycle.
From product feedback and complaints to service, repairs, returns, post-market surveillance, and regulatory reporting, Vigilia brings healthcare organizations and life sciences manufacturers together through structured, transparent, and traceable workflows.
Designed to improve how healthcare product information is reported, coordinated, resolved, and understood—across the organizations responsible for product performance, quality, and safety.
The Challenge
Healthcare product safety is a shared responsibility. The information isn't always shared.
Every day, healthcare professionals and manufacturers encounter valuable information about how healthcare products perform in real-world environments.
A clinician reports a product concern. A biomedical engineer requests technical support. A service team identifies a recurring failure. A manufacturer investigates a complaint. A quality team evaluates an emerging product trend.
These activities may involve the same product, but the information often travels through different systems, teams, and organizations.
The result is fragmented visibility across the healthcare product lifecycle.
Disconnected reporting
Product feedback, complaints, and technical concerns are communicated through emails, phone calls, spreadsheets, and individual manufacturer portals.
Fragmented service and resolution
Service requests, repairs, returns, replacements, and technical support activities may be managed separately from product quality records.
Limited post-market visibility
Recurring product issues, use errors, and performance trends can be difficult to recognize when relevant information remains distributed across organizations.
Complex regulatory coordination
Complaint investigations, recalls, corrections, removals, and regulatory reporting activities require timely access to accurate, traceable information.
The challenge isn't a lack of information. It's the difficulty of bringing that information together when it matters.
The Scale
Millions of reports. The work around them is harder to see.
10
work days for device user facilities to report certain device-related deaths and serious injuries through the applicable MDR pathway
Deaths are reported to FDA and the manufacturer; serious injuries to the manufacturer, or FDA if the manufacturer is unknown.
U.S. Food and Drug Administration
21 CFR
PART 803
Medical Device Reporting requirements for manufacturers, importers, and device user facilities
Device user facilities have specific procedures, records, and reporting responsibilities for certain medical device events.
U.S. Food and Drug Administration
Sources
U.S. Food and Drug Administration — MDR Data Files · Mandatory Medical Device Reporting Requirements
Introducing Vigilia
A unified approach to healthcare product safety.
Vigilia is building a cloud-based platform designed to support healthcare product safety, quality, service, and vigilance across organizational boundaries.
By bringing product-related activities into structured workflows, Vigilia aims to improve visibility, coordination, and traceability from the first reported concern through investigation, resolution, and post-market analysis.
Instead of relying on disconnected communications and isolated records, participating organizations can work from a clearer understanding of product-related activities and their status.
One product. Multiple stakeholders. Shared visibility.
How Vigilia Works
Five pillars. One unified experience.
01 — Report
Capture the information that matters.
Report product feedback, complaints, use errors, enhancement requests, and other product-related concerns through structured workflows.
Support more complete intake with relevant product details, event information, and supporting documentation.
02 — Connect
Bring the right organizations and teams together.
Facilitate communication and coordination between healthcare organizations, manufacturers, service teams, and other participating stakeholders.
Help relevant information reach the people responsible for evaluating and addressing product-related concerns.
03 — Resolve
Coordinate the actions that follow.
Support complaint-related activities, technical assistance, service and repair requests, product returns, replacements, and other resolution workflows.
Improve clarity around responsibilities, next steps, and communication.
04 — Track
Maintain visibility from report to resolution.
Track product-related requests, follow-up activities, status updates, and supporting records through structured, traceable workflows.
Help teams understand what has been reported, what actions are underway, and what remains unresolved.
05 — Learn
Turn product information into actionable intelligence.
Bring together relevant post-market information to help teams identify recurring concerns, product performance trends, use errors, and opportunities for earlier intervention.
Support more informed decisions across product quality, safety, and operational functions.
Who We Serve
Different responsibilities. A shared commitment to product safety.
Healthcare product safety depends on organizations with different responsibilities, systems, and perspectives.
Vigilia is designed around the information and workflows that connect them.
For Healthcare Organizations
Simplify product reporting, support, and resolution.
A unified experience for reporting product feedback and complaints, requesting service and repairs, coordinating returns and replacements, accessing technical support, and tracking actions through resolution.
Gain visibility into recurring product safety and performance concerns, use errors, and product incompatibilities across healthcare products.
For Life Sciences
From fragmented interactions to actionable post-market intelligence.
Support structured product feedback and complaint management, service and repair coordination, product returns, enhancement requests, post-market surveillance, IMDRF coding, and regulatory workflows.
Improve visibility into recurring product concerns and customer experiences while supporting collaboration across quality, regulatory, engineering, and service organizations.
For GPOs & Distributors
Improve coordination across healthcare supply chain partners.
Support the communication and coordination of product complaints, recall notifications, corrections and removals, returns, and manufacturer-related activities across participating healthcare organizations and supply chain partners.
Help improve traceability and visibility into product-related actions across the supply chain.
Vigi AI
Product intelligence, when and where it matters.
Healthcare product information is valuable. Understanding the relationships between records, events, products, and activities can make it more useful.
Meet Vigi AI, Vigilia's AI-powered assistant.
Vigi AI is being developed to help teams access relevant product information, recognize recurring concerns, identify emerging trends, and support more informed decisions.
Find relevant information
Navigate product-related records and supporting information more efficiently.
Recognize emerging patterns
Support identification of recurring product concerns, failure patterns, use errors, and product incompatibilities.
Support investigations
Bring relevant product context together to assist quality, service, and technical teams.
Improve documentation
Assist with structured information, classification, and post-market documentation activities.
Support timely escalation
Help surface concerns that may warrant additional investigation or review.
Vigi AI is intended to support professional judgment—not replace qualified personnel responsible for safety assessments, investigations, and regulatory decisions.
Why Vigilia
Designed around how healthcare product information actually moves.
Traditional systems often focus on the responsibilities of a single organization or department.
Yet healthcare product safety involves interactions between clinical users, biomedical engineering, manufacturers, quality teams, service organizations, and supply chain partners.
Vigilia's approach begins with those interactions.
- Shared, not siloed.
- Connected, not fragmented.
- Structured, not informal.
- Visible, not buried.
- Proactive, not reactive.
By maintaining context across product-related activities, Vigilia aims to help organizations make better use of the information already being generated throughout the healthcare product lifecycle.
Working Alongside Existing Systems
Strengthening workflows without replacing what already works.
Healthcare organizations and life sciences manufacturers rely on established quality management systems, service platforms, clinical applications, and enterprise systems.
Vigilia is designed to address the gaps in communication, coordination, and visibility that can exist between these environments.
Its role is to help participating organizations manage product-related interactions through a unified experience while supporting their established responsibilities and processes.
From the first product concern to investigation, resolution, and post-market learning.
Our Mission
Advancing patient safety by advancing product quality.
We believe healthcare product safety should be a shared, proactive responsibility across the organizations that develop, distribute, use, service, and monitor healthcare products.
Vigilia was founded to help make that responsibility easier to coordinate through better information, structured workflows, and greater visibility across the healthcare product lifecycle.
Healthcare product safety deserves a better way forward.
Whether you're responsible for clinical operations, biomedical engineering, product quality, post-market surveillance, regulatory affairs, or technical service, Vigilia is being built around the challenges your teams encounter.
Discover how Vigilia can support your organization's approach to healthcare product safety and vigilance.