VigiX 360 — Bioexcel’s Integrated Medical Device Compliance & Evidence Platform

Unifying Clinical Investigations, Clinical Evaluation, Real-World Evidence, Materiovigilance, and PMS reporting into one structured,audit-ready system.

Designed for manufacturers operating under EU MDR, ISO 14155, ISO 13485, FDA, CDSCO, and global vigilance frameworks.

WHY VIGIX 360

  • Clinical investigations in one system
  • CER in documents
  • PMCF data in spreadsheets
  • Complaints in ticket tools
  • PMS reports manually compiled
  • Risk and CAPA disconnected

This creates regulatory risk and operational inefficiency.

VigiX 360 connects the entire evidence lifecycle.

CORE DESIGN PRINCIPLE

One Shared Core Platform + Switchable Modules

  • Modular activation per
  • Multi-product scalability
  • Region-specific rule configuration
  • Full lifecycle traceability
    This ensures compliance
  • PMS reports manually compiled
  • Risk and CAPA disconnected

This ensures compliance maturity without operational chaos.

PLATFORM MODULES (UPDATED – INCLUDING RWE / PMCF)

Clinical Investigation Operations + Safety Reporting

(ISO 14155 Aligned)

  • Study documentation management
  • AE / SAE intake & assessment workflows
  • Causality & seriousness evaluation
  • Expectedness classification
  • Reporting timeline tracking
  • Safety documentation outputs
  • Investigator collaboration (optional portal)

Ensures structured safety oversight and audit readiness.

Clinical Evaluation Management

(CER / CEP / Benefit-Risk)

  • Clinical Evaluation Plan structuring
  • Literature tracking & appraisal
  • Clinical data mapping
  • Benefit–risk alignment documentation
  • Evidence traceability
  • Structured CER outputs

Direct linkage to:

  • PMCF findings
  • RWE data
  • Complaint trends
  • Risk updates

Post-Market Materiovigilance

Complaint Assessment Investigation Regulatory Reporting CAPA Risk Update
Includes:

  • Complaint intake management
  • Reportability decision workflows
  • Root cause documentation
  • Regulatory timeline tracking
  • Field Safety Corrective Action documentation
  • Trend dashboardst

All actions fully timestamped and audit-traceable.

PMS / PSUR / PMSR Engine

  • PMS Plan tracking
  • Data aggregation across modules
  • Trend analysis workflows
  • Signal detection review
  • Periodic report structuring
  • Management review documentation

Automatic integration from:

  • Complaints
  • Clinical investigations
  • RWE/PMCF outputs
  • CAPA actions
  • Literature updates

Liminates manual report compilation.

RWE/PMCF Module

(Real-World Evidence & Post-Market Clinical Follow-Up)

This module transforms VigiX 360 into a continuous evidence intelligence system.

What is RWE in VigiX 360?

Real-World Evidence (RWE) captures device performance and safety data from real-world use environments.

Typically sourced from:

  • PMCF studies
  • Surveys
  • Registries
  • Observational follow-ups
  • Hospital datasets
  • Complaint & servicing data
  • Published real-world literature

PMCF Management Capabilities

VigiX 360 structures:

  • PMCF Planning workflows
  • PMCF Study tracking
  • Survey creation & tracking
  • Follow-up documentation
  • Data collection oversight
  • Registry tracking

Outputs include:

  • PMCF Plan
  • PMCF Evaluation Report
  • Structured evidence summaries

Complaint & Servicing Data as Evidence

VigiX 360 allows:

  • Linking complaint data to RWE dashboards
  • Linking service records to safety trends
  • Structured device performance tracking

This converts routine post-market data into usable clinical evidence.

Published RWE Integration

  • Literature tracking for real-world studies
  • Structured evaluation & linkage to CER
  • Evidence package creation