The Challenge
Medical device regulatory teams face an overwhelming information landscape:- Information overload: Hundreds of regulatory updates daily across FDA, EMA, NMPA, Health Canada, TGA
- Relevance filtering: Which updates actually affect your products?
- Delayed awareness: Learning about critical changes too late
- Impact assessment: Understanding what actions are required
- Cross-functional coordination: Notifying the right teams at the right time
How MedStrato Helps
MedStrato’s Signals module provides real-time regulatory intelligence:Multi-Source Monitoring
Aggregate signals from FDA, EMA, NMPA, Health Canada, TGA, and industry news.
AI Analysis
Automatic summarization, sentiment analysis, and key points extraction.
Product Correlation
Auto-detect which signals affect your specific products with confidence scores.
Impact Assessment
Classify signals by impact level (Critical/High/Medium/Low) with actionable next steps.
Step-by-Step Workflow
Step 1: Configure Your Signal Sources
MedStrato monitors regulatory authorities automatically:| Source | Coverage | Update Frequency |
|---|---|---|
| FDA | US medical device regulations, 510(k), PMA, recalls | Daily |
| EMA | EU medical device regulations, MDR updates | Daily |
| NMPA | China medical device regulations | Daily |
| Health Canada | Canadian medical device licensing | Daily |
| TGA | Australian therapeutic goods | Daily |
| Industry News | Medical device industry publications | Continuous |
Step 2: Review the Signal Dashboard
- Go to Signals from the main navigation
- View signals in two modes:
- Map View: Geographic visualization of signal sources worldwide
- List View: Sortable, filterable table of all signals
- Title: Headline of the regulatory update
- Source: Which authority or publication
- Date: When it was published
- Impact Level: Critical, High, Medium, or Low
- Sentiment: Positive, Neutral, or Negative
Step 3: Filter for Relevance
Use filters to focus on what matters:| Filter | Options |
|---|---|
| Source | FDA, EMA, NMPA, Health Canada, TGA, Industry |
| Impact Level | Critical, High, Medium, Low |
| Sentiment | Positive, Neutral, Negative |
| Product | Your registered products |
| Time Range | Today, Week, Month, Quarter, All |
Step 4: Analyze Signal Details
Click any signal to open the detail panel:AI-Generated Summary
A concise 2-3 sentence summary of the regulatory update, written in plain language.Key Points
Bullet-point extraction of the most important information:- What changed?
- Who is affected?
- What are the deadlines?
Impact Assessment
| Field | Description |
|---|---|
| Impact Level | Critical / High / Medium / Low |
| Impact Score | 0-100 numeric score |
| Impact Category | Regulatory, Compliance, Safety, Market, Technology |
| Impact Description | Detailed explanation of business implications |
Next Steps
AI-generated actionable recommendations:- “Review product labeling for compliance with new requirements”
- “Schedule internal review meeting within 2 weeks”
- “Update quality management system documentation”
Step 5: Assess Product Impact
MedStrato automatically correlates signals with your registered products:- Open a signal detail
- View the Product Relevance section
- See affected products with:
- Relevance Type: Direct, Indirect, or Potential
- Confidence Score: 0-100% certainty
- Relevance Explanation: Why this product is affected
Setting Up Products
For best results, register your products in MedStrato:- Go to Products from the main navigation
- Click New Product
- Enter product details:
- Name and description
- Regulatory classification
- Target markets (US, EU, China, etc.)
- Key therapeutic areas
Step 6: Take Action
Bookmark Important Signals
- Click the bookmark icon to save signals for later review
- Access bookmarked signals from the filter menu
Create an Investigation
For complex regulatory changes, promote a signal to a full investigation:- Open the signal detail
- Click Create Investigation
- MedStrato generates a research framework based on the signal
- Generate a comprehensive report with AI analysis
Share with Your Team
- Mark signals for team review
- Add notes with your analysis
- Export signal reports for meetings
Step 7: Monitor Continuously
MedStrato provides real-time monitoring:- Live Indicator: Shows when background signal fetching is active
- Unread Signals: Badge showing new signals since your last visit
- Archive: Move resolved signals out of your active view
- Check Critical/High signals each morning
- Review product-correlated signals weekly
- Archive processed signals to keep your dashboard clean
Signal Categories and Response
| Impact Level | Typical Content | Recommended Response |
|---|---|---|
| Critical | Recalls, safety alerts, immediate compliance requirements | Same-day review, escalate to leadership |
| High | New regulations, significant guidance changes | Within 48 hours, cross-functional review |
| Medium | Draft guidance, industry trends, competitor actions | Weekly review, track for developments |
| Low | Minor updates, general news, informational content | Monthly review, archive as needed |
Real Results
Regulatory teams using MedStrato typically see:- 60% reduction in time spent scanning regulatory sources
- Earlier awareness of critical changes (hours vs. days)
- Better product-signal correlation accuracy over time