verified_user For QMS Use: Validation Required

This tool must be formally validated for its intended use within your Quality Management System (QMS) per FDA 21 CFR 820.70(i) and ISO 13485:2016. The risk criteria used (matrices, levels, thresholds) must be verified to match your organization's established and approved Risk Management Plan (e.g., OP047).

Risk Management Lifecycle Tools

A suite of interactive tools to assess, re-evaluate, and report on product risk throughout its lifecycle, from initial assessment to post-market surveillance.

Session Management

Save your work progress and resume later. Perfect for year-long reporting tasks.

Your sessions are securely stored in dedicated cloud folders for easy access anytime.

Cloud Storage - Saved Sessions

Automatically organize your work in dedicated folders. Access from any device, any time.

Organization Folder:

Choose an existing folder or type a new name to organize your sessions

Local Device - Quick Backup

Save to your computer for offline backup or sharing via email.

Module 1: Re-evaluate Probability From Data

trending_up Purpose: Process Post-Market Complaint Data

This is the starting point for post-market surveillance. Use your total complaint data to see if the real-world probability matches your prediction.

arrow_forward Next Step: Use the new probability level from this result in Module 3.

Initial Predicted Probability: Total Number of Confirmed Events:

Denominator Type:

Total Number:

Re-evaluation Result:

Module 2: Re-evaluate Severity & Plan Action

warning Purpose: React to Unexpectedly Severe Harm

Use this if a complaint reveals a harm was more severe than what is documented in your RMF.

arrow_forward This tool provides a final action plan based on the new, more severe outcome.

Current Probability for this Risk: Newly Discovered Severity Level:

Action Plan:

Module 3: The Core Risk Matrix

assignment Purpose: Assess or Re-assess Overall Risk

For new risks: Use this module first to establish a baseline.
After re-evaluation: Use this module AFTER using Module 1 or 2 to see the full impact of new data.

Probability of Occurrence: Severity of Harm:

Result:

Module 4: Quantitative Benefit-Risk Analysis

balance Purpose: Justify Risk Acceptability

Use this module when a risk from Module 3 is MEDIUM (Yellow) or HIGH (Red). This provides a quantitative score to justify that the medical benefit outweighs the residual risk.

arrow_forward Select a device profile to begin.

Select Device Profile:

Select One or More Hazards to View:

Select a device first...

Scale Definitions

Magnitude of Benefit / Severity of Harm:

1: Minor / Inconvenience
2: Prevents minor injury / Temporary injury (no intervention)
3: Prevents injury requiring intervention / Injury requiring intervention
4: Prevents permanent impairment or life-threatening injury
5: Life-saving / Patient Death

Total Units Sold/Used This Period:

Risk Description (from RMF)	Reference	Severity	Baseline PPM	IMDRF Code	FDA Code	New Events	Current PPM
Select a device profile to see risks.

Module 5: SPC Trend Analysis (Rolling 12 Months)

bar_chart Purpose: Detect Statistically Significant Trends

Enter your time-series data (at least 12 points), **oldest to most recent**. The analysis will automatically be performed on the **latest 12 data points**.

arrow_forward A "SIGNAL DETECTED" provides objective evidence that an investigation is required.

Data Entry Options

Option A: Table Entry (Recommended)

Enter data directly into the table below. Month labels are auto-generated.

#	Period/Month	Events	Units Shipped	Actions

Option B: Bulk Text Entry

Events per Period (oldest first):

Units Shipped per Period (oldest first):

Option C: Import/Export CSV

upload_file Import from CSV

Select Nelson Rules to Apply:

Rule 1: Point > UCL

Rule 2: 9+ on one side

Rule 3: 6+ trending

Rule 4: 14+ alternating

Rule 5: 2/3 > 2σ

Rule 6: 4/5 > 1σ

Rule 7: 15+ within 1σ

Rule 8: 8+ outside 1σ

Control Chart:

Analysis Result:

Module 6: Generate Risk Profile Report

description Purpose: Consolidate Analysis into a Formal Report

After using the modules above, enter the final details below and generate a formal, printable report for your RMF.

Governing Risk Management Plan ID:

Device Name / Family:

Failure Mode / Risk Being Assessed: Identified Hazard(s): Potential Harm(s): Current Risk Control Measures:

Attestation & Report Generation

Performer's Printed Name:

I attest that the data entered is accurate and sourced from the official QMS, and that the analysis was performed according to the governing Risk Management Plan.

Reviewer's Printed Name (Optional):

I attest that I have reviewed this analysis for accuracy and completeness according to the governing Risk Management Plan.

View all electronically signed statistical analysis reports and their corresponding audit records.

Audit Trail