Pathway – regulatory intelligence you can use

Get instant alerts when new regulations are published globally, 
then use AI-powered analysis to understand exactly what they mean for your specific devices. No more spending days deciphering if a 100-page guidance applies to you. Pathway delivers clarity in minutes, not weeks.

Connected Safety Monitoring

Post-market surveillance efforts collapse under siloed data, manual tracking, and growing regulatory pressure — making safety oversight reactive instead of proactive

01
Disconnected Teams
Data Silos Create Blind Spots

Safety insights remain trapped in departments. Without shared visibility, key risks go unnoticed and unresolved.

02
Unscalable Workflows
Manual Processes Don’t Scale

Excel sheets and email can’t keep up with 50+ products. Teams spend more time organizing data than analyzing it.

03
Rising Risk
Regulatory Stakes Keep Rising

MDR and FDA expectations grow stricter every year. Mistakes now lead to costly recalls, warning letters, and patient safety issues.

04
Reactive Reporting
Too Late to Act

Issues surface only after complaints escalate. 
Without proactive monitoring, you respond when it’s already a problem.

Features that power scalable, proactive safety monitoring

Vigilance unifies post-market surveillance, automates workflows, and helps you act on safety signals before they escalate

Intelligent duplicate removal

The system automatically detects duplicates by DOI, PMID, and titles and offers manual validation if necessary.

Automate PSUR Scheduling

Set report frequencies and deadlines by product class. The system tracks due dates and reminds you automatically.

Centralize Global Surveillance

Manage local and international data in one system. No more spreadsheets or fragmented dashboards.

Generate reports to meet regulatory requirements

Export in formats for MDR, IVDR, FDA with PRISMA, EndNote, Word, Excel.

Catch Every Signal

Aggregate data from complaints, literature, MAUDE, and more. Nothing slips through the cracks.

Main features
Evidence Cloud™:

Spot Safety Trends Early

Built-in analytics detect patterns and emerging risks. Act before issues grow.

Intelligent duplicate removal

The system automatically detects duplicates by DOI, PMID, and titles and offers manual validation if necessary.

Scale Without Adding Headcount

Configurable workflows and alerts keep your team focused. Handle growing product lines with ease.

Generate Submissions in Hours

Pre-built PSUR and report templates pull from real-time data. Submit with confidence and speed.

Generate reports to meet regulatory requirements

Export in formats for MDR, IVDR, FDA with PRISMA, EndNote, Word, Excel.

A clear path from fragmented inputs to proactive safety reporting

Vigilance connects all your post-market data, monitors signals in real time, and prepares regulatory submissions in a streamlined, structured flow.

Step-by-step process   
  • Connect Data Sources
  • Monitor & Capture
  • Review & Analyze
  • Report & Submit

Evidence Cloud Automation

Pathway integrates with your quality systems and document control platforms.
Updates flow directly into your compliance calendar. Export summaries to your QMS.
Link regulatory requirements to your technical documentation.

MANUAL APPROACH

Compliant data copied across systems

MANUAL APPROACH

Manual search and copy

MANUAL APPROACH

Search, save, and upload separately

MANUAL APPROACH

Separate inputs, manual syncing

MANUAL APPROACH

Files added manually

MANUAL APPROACH

CAPAs tracked in isolation

Salesforce Service Cloud
FDA MAUDE database
PubMed and literature
QMS Platforms
Document Control Systems
CAPA Platforms

Auto-ingested from Salesforce

EVIDENCE CLOUD™

Continuous automated monitoring

EVIDENCE CLOUD™

Sources linked and tracked natively

EVIDENCE CLOUD™

Fully integrated post-market updates

EVIDENCE CLOUD™

Versioned and tracked automatically

EVIDENCE CLOUD™

Linked directly to surveillance actions

EVIDENCE CLOUD™

100%

on-time PSURs

Reports submitted without delays or escalations.

40 Hours

saved per report

PSURs, complaints, and safety trends delivered instantly.

Trusted for global safety surveillance

Vigilance delivers control and visibility in post-market surveillance. Built to scale with your portfolio while reducing risk and effort.

20+

global data sources

Critical safety data captured before it’s too late.

43%

fewer audit findings

Observed across teams switching from manual workflows.

Evidence Cloud™ is built to meet the standards that matter in regulatory work

SOC 2 Type II Certified

Compliance with security, confidentiality and accessibility requirements in accordance with international auditing standards.

HIPAA Compliant

The platform complies with the requirements for the protection of medical information in accordance with US regulations.

Built on Salesforce

Robust Salesforce-based architecture – proven, scalable, and adaptable to change.

FDA Validated Processes

The processes for developing and using the modules meet the FDA’s expectations for transparency, controllability, and auditability.

All modules connected in one platform

Evidence Cloud™
Module Connections

Literature
CiteSource
Pathway
ReadyView
Vigilance

Literature CiteSource

  • Auto-populate reference library from reviews

  • Access shared organizational collections

  • Import existing citations for new reviews

  • Export results to knowledge base

Literature ReadyView

  • Real-time review progress dashboards

  • Screening funnel visualization

  • AI effectiveness and performance metrics

  • Meta-analysis with forest plots

CiteSource Literature

  • View all historical literature review project data

  • Cumulative device history across all reviews

  • Access to all identified and screened literature

  • Seamless reference import/export

CiteSource Vigilance

  • Import adverse event literature directly

  • Tag and categorize safety references

  • Share validated safety literature across teams

  • Export citations for PSUR reporting

CiteSource Pathway

  • Organize regulatory guidance documents

  • Link clinical evidence to requirements

  • Tag references by regulatory pathway

  • Export pathway-specific collections

CiteSource ReadyView

  • Visualize reference usage patterns

  • Track citation metrics across departments

  • Monitor library growth and utilization

  • Generate citation analytics reports

Pathway CiteSource

  • Store regulatory guidance documents

  • Link evidence to pathway requirements

  • Build submission reference packages

  • Track citations by jurisdiction

Pathway Vigilance

  • Integrate safety with submission timelines

  • Map vigilance to regulatory pathways

  • Coordinate PMCF with strategy

  • Track post-market obligations

Pathway Literature

  • Search literature across all historical projects

  • Access any previously reviewed article

  • Generate requests for specific literature searches

Pathway ReadyView

  • Find reports and charts related to your search

  • Export search results from multiple sources

  • Generate executive briefings from searches

ReadyView Literature

  • Comprehensive review analytics

  • Evidence quality visualizations

  • Team performance insights

  • Publication trend analysis

ReadyView Vigilance

  • Real-time adverse event monitoring

  • Compliance tracking visualizations

  • Comparative safety analysis

  • Automated KPI reporting

ReadyView CiteSource

  • Library utilization analytics

  • Citation pattern analysis

  • Knowledge sharing metrics

  • Literature gap identification

ReadyView Pathway

  • Create AI powered presentations

  • Generate reports from multiple evidence sources

  • Share regulatory intelligence across your company

Vigilance CiteSource

  • Access centralized adverse event repository

  • Import safety signal references

  • Maintain compliant citation documentation

  • Share safety literature cross-functionally

Vigilance ReadyView

  • PSUR, Vigilance report generation

  • Multi-Series event trending charts

  • Benefit-Risk visualization

  • Live safety monitoring dashboards

Vigilance Pathway

  • Search and organize safety signals

  • Track vigilance obligations by jurisdiction

  • Map events to reporting timelines

  • Coordinate safety with submissions

FAQ

Frequently asked questions
about the CiteSource module

Answers to key questions that will help you better understand the functionality,
flexibility, and application of the module in your process.

Would you like to get a consultation? Contact the team

14 days demo access

Ready to Master Regulatory Complexity?

Stop buying the same articles twice. Start building your permanent reference library

Other modules
that work with Pathway

Evidence Cloud™ is not a separate tool, but an interconnected system.
The CiteSource module integrates with other parts of the platform to build
a full cycle of regulatory documentation

Smarter, Faster, Accurate Literature Reviews

5 Major Concerns for Software As a Medical Device and AI Companies

Move over, Dr House, there's a new diagnostician in town, and it's not human! Thanks to the power of AI, medical devices are becoming smarter than ever, analyzing data faster than ever and creating regulatory headaches as they go.   From detecting irregular heartbeats to identifying suspicious moles, these devices are the ultimate sidekick for [...]

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7 Qualities of a Fantastic Medical Writer

Medical writers make up much of the medical device regulatory industry. In fact, they are one of the largest contributors behind the thousands of devices that get conformity approval each year. However, good medical writers are hard to come by. The thing is, you need a very specific set of skills to become a [...]

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An Overview of the CE Marking Process in the European Union

You want to sell your device in the European Union and start the CE marking process. But after reviewing the MDR and the guidance documentation, you begin to doubt the CE mark process.   Are clinical evaluations before or after product development? Do you need post-market surveillance or post-market clinical follow-up? And what even is [...]

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Analyzing the Differences between CERs for MDR versus MDD

Implementing the MDR or Medical Device Regulation will bring significant changes to the process of Clinical Evaluation and subsequent post-market compliance requirements. This, of course, is a significant concern for medical device manufacturers in the EU. Some changes may be relatively minor, such as the change in terminology from Essential Requirements to General Safety and Performance [...]

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Are You Over-Committing on Your EU MDR Post-Market Surveillance Plan?

All MedTech companies face increased post-market surveillance (PMS) requirements under the EU MDR and IVDR. A PMS plan will incorporate a Post-Market Clinical Follow-up (PMCF) plan or justification for why it is unnecessary.   Higher-risk devices and IVDs require a Periodic Safety Update Report (PSUR). While for lower-class devices, a Post-Market Surveillance Report (PMSR) [...]