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VigiX

Next-Gen Materiovigilance & Complaint Management System

Smart Compliance. Safer Devices. Global Trust.

What is VigiX?

VigiX is Bioexcel's AI-powered software platform built to streamline and automate materiovigilance and post-market surveillance (PMS) for medical devices.

It empowers manufacturers, regulatory affairs teams, and clinical professionals to manage complaints, conduct root cause investigations, track CAPA, and submit global regulatory reports (FDA eMDR, EU MIR, IMDRF) effortlessly.

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A powerful software platform for medical device complaint intake, assessment, regulatory reporting, and post-market surveillance.

Why Effective Complaint Handling Matters

Medical device complaints can be a goldmine of insights or a regulatory nightmare.

Regulatory bodies like the FDA and EU have strict expectations for how you handle complaints – one misstep can trigger warning letters, hefty fines, or even product seizures. In fact, complaint files and related CAPA failures are among the top issues cited in FDA warning letters and failing to maintain proper complaint procedures risks import bans and costly recalls

Every complaint, no matter how minor, is a signal that something could be wrong. If underlying issues aren’t identified and addressed, a simple device hiccup can escalate into a serious recall, compliance violation, or worst of all, patient harm. Effective complaint handling isn’t just about ticking boxes – it’s about ensuring product quality, patient safety, and regulatory adherence

Unfortunately, many companies struggle with complaint management. Common pitfalls include under-trained intake staff miscategorizing issues, incomplete or inaccurate records, poor cross-functional communication, and slow closure leading to backlogs. These mistakes create compliance gaps and let problems fester. The good news? With a well-structured system, these challenges can be managed easily That’s where VigiX comes in – to turn complaint handling from a pain point into a competitive advantage.

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Why Choose VigiX?

Built on ISO 13485 and EU MDR frameworks

Compliant with FDA 21 CFR 803 (eMDR), EU MIR Form 7.3.1, IMDRF standards

Fully supports multilingual complaint intake and document mapping.

AI-driven deduplication, classification, and trend detection

Enables risk-based prioritization and auto-escalation

One-click export for PSUR/PMSR generation

Supports IVD and Implantable Device templates

Key Features and Capabilities

VigiX provides end-to-end complaint lifecycle management, packed with intelligent features that make the process efficient and 

AI-Powered Complaint Management

Automate complaint intake from Emails, Web Portals, and CRMs.

Regulatory-Ready Triage & Seriousness Assessment

Smart Prioritization for Global Regulatory Compliance

Built-in Root Cause Analysis (RCA) Tools

From Complaint to Investigation — Without Switching Systems

Fully Integrated CAPA Management

Turn Insights into Action, Track Every Step

Automated Global Regulatory Reporting

Compliant with EU MDR, FDA MDR, CDSCO, TGA & More

Smart SOP Compliance Tracking

Always Work with the Right SOP — Automatically

Real-Time Dashboards & Trend Analytics

Make Proactive Decisions with Live Insights

Audit-Ready Documentation & Traceability

Be Inspection-Ready at All Times

Who Is It For?

Implementing VigiX delivers tangible benefits across your organisation.

Medical Device & IVD Manufacturers

VigiX turns complaints into quality wins. Smart, fast links to CAPA & design changes.

CRO or PMS firm

VigiX ensures every complaint is captured and analyzed, reducing human error and enabling early risk detection with AI.

Regulatory Affairs Teams

VigiX automates compliance and complaint reporting. Be audit-ready with complete, timely records.

Quality Assurance Departments

It drives faster, coordinated resolutions across teams, improving patient safety and building provider trust.

Why CROs & PMS Firms Need VigiX

Automated intake, triage, and reporting reduce manual cycles.

Provide high-value dashboards, FSCA support, and global reporting services to stand out from other CROs.

Built-in mapping to IMDRF, MedDRA, EU MDR, FDA eMDR, and CDSCO formats.

One platform to manage 10 or 1000 clients — all with tailored workflows and data access controls.

Robust complaint handling is no longer a “nice to have” – it’s mission-critical for compliance and customer loyalty.

VigiX provides the technology and workflows to make it happen. Don’t let device issues turn into regulatory nightmares or missed improvement opportunities.

Contact us today for a personalised demo and see how VigiX can help your team streamline complaints management, ensure regulatory compliance (EU MDR, FDA, IMDRF and more), and ultimately deliver safer, higher-quality medical devices to the market.

Let VigiX help you turn every complaint into a catalyst for excellence.

Book a free demo and explore:

  • Dashboard walkthrough
  • Real-world use cases (IVDs, implants)
  • Global reporting workflows

Services & Description

Service Description
Complaint Intake &
Workflow Automation
Centralized complaint intake forms (web + mobile) for sponsors or clients. Use VigiX to automate triage. helps automate triage, case tracking, and de-duplication.
Safety Signal Detection &
Trend Analysis
CROs can monitor adverse event trends across products and geographies using real-time AI-based dashboards.
Multi-Client Regulatory
Reporting
Prepare, manage, and submit global regulatory reports (e.g., EUMDR , MIR, FSCAs) for multiple sponsors with region-specific rules built-in.
FSCA Coordination &
CAPA Monitoring
Manage field safety actions and corrective/preventive plans with built-in timeline tracking, stakeholder communication logs, and evidence uploads.
PMCF & PSUR/PMSR
Support
Use VigiX to auto-generate Post-Market Clinical Follow-up (PMCF) plans, and collate PMSR/PSUR data from aggregated logs and external sources.
Client-Branded
Dashboards
Offer each sponsor company a branded dashboard view — powered by your CRO license on VigiX — for shared compliance transparency.
Customizable Workflows &
Templates
Implement unique SOP-driven forms, review layers, and approval roles for each client project with zero coding.
Smart Audit Trails &
Exportable Logs
Maintain GDPR-, EU MDR-, and FDA-compliant audit trails. Export sponsor-specific summaries for inspections or reviews.

Client Testimonial

VigiX helped us transform our complaint management process and reduce submission delays by 70%. It's now a central part of our regulatory compliance stack.

Regulatory Head Leading EU-based Device Manufacturer

It is a paradisematic country, in which roasted parts of sentences fly into your mouth. Even the all-powerful Pointing has no control about

Charles Dawson Founder & CEO of XpeedStudio

It is a paradisematic country, in which roasted parts of sentences fly into your mouth. Even the all-powerful Pointing has no control about

Ethan Reed Founder & CEO of XpeedStudio

It is a paradisematic country, in which roasted parts of sentences fly into your mouth. Even the all-powerful Pointing has no control about

Ryan Bennett Founder & CEO of XpeedStudio

It is a paradisematic country, in which roasted parts of sentences fly into your mouth. Even the all-powerful Pointing has no control about

William Brooks Founder & CEO of XpeedStudio

Let’s Co-Create the Future of Compliance

VigiX empowers CROs and PMS firms to do more than manage data — it lets you lead your sponsors through global compliance with speed, accuracy, and automation.

👉 Partner with us and scale your post-market service portfolio today.