# Predictive Risk Management | Botable Glossary

https://www.botable.ai/glossary/predictive-risk-management

Useful for understanding the vendor’s definition and framing of PRM and for high-level regulatory context; attribute claims to the site when quoting and consult primary regulations or guidance for compliance decisions.

## Summary

Predictive Risk Management (PRM) is defined as a forward-looking, data-intensive QMS approach that uses big data, machine learning, and advanced analytics to identify and mitigate potential quality risks before they occur. The page explains PRM’s basis in risk-based thinking and preventive action, describes enabling technologies (AI/ML/IoT), and outlines regulatory expectations for predictive medical-device software.

## Audience

quality and regulatory professionals (QMS teams), medical device and life-sciences teams

## Prompts this page answers

- What is Predictive Risk Management in a Quality Management System?
- How does predictive analytics apply to QMS and preventive action?
- What regulatory considerations are listed for predictive medical-device software?
- Which technologies enable predictive risk management (AI/ML/IoT) in quality systems?

## Purpose

Inform and explain the concept of Predictive Risk Management within quality management systems and its application and regulatory considerations in medical-device software.

## Highlights

- Predictive Risk Management (PRM) uses big data, machine learning, and advanced analytics to identify potential quality risks before they occur.
- PRM represents an extension of risk-based thinking and preventive action as emphasized in modern QMS standards such as ISO 9001.
- Enabling technologies listed include AI, machine learning, IoT, real-time monitoring, and predictive analytics for proactive intervention.
- For predictive medical-device software, manufacturers must perform comprehensive hazard analysis, verification, and validation; specific device examples include coronary physiologic simulation software, adjunctive predictive cardiovascular indicators, and predictive pulmonary-function calculators.
- Regulatory expectations for predictive device software include scientific justification, algorithm validation on independent data sets, and performance-characteristic labeling (e.g., sensitivity, specificity, PPV, NPV).

## How to cite

https://www.botable.ai/glossary/predictive-risk-management

## Publisher



## Topics

- predictive risk management
- QMS predictive analytics
- risk-based thinking
- preventive action (PA)
- predictive medical device software

## Key entities

- **Botable** (organization): Site and glossary publisher brand. — https://www.botable.ai/
- **ISO 9001** (other): Modern QMS standard referenced in the page.
- **FDA** (other): U.S. regulator implicitly referenced in the regulatory requirements section for predictive devices.
- **Corrective and Preventive Action (CAPA)** (other): CAPA concept and internal link referenced on the page. — https://www.botable.ai/blog/capa-system-ai-the-future-of-corrective-and-preventive-actions
- **Coronary Vascular Physiologic Simulation Software** (other): Example class of prescription predictive device described on the page.
- **Adjunctive Predictive Cardiovascular Indicator** (other): Example prescription predictive device described on the page.
- **Predictive Pulmonary-Function Value Calculator** (other): Example Class II predictive device described on the page.

## Metadata

- Type: article