ISO 13485 Risk Management Primer
Integrating ISO 14971 with your QMS — a foundational guide to medical device risk management that helps you avoid common FDA observations.
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What You'll Get
- Understand ISO 14971 fundamentals
- Learn QMS integration points
- Review real-world risk examples
- Avoid common FDA 483 observations
The Challenge
Medical device companies often struggle to properly integrate risk management into their QMS. FDA inspectors frequently cite inadequate risk management as a 483 observation, and notified bodies scrutinize the risk management file closely.
The Solution
This primer explains the relationship between ISO 13485 and ISO 14971, shows you the key integration points, and provides practical examples of effective risk management documentation.
Inside This Resource
- 1ISO 14971 Fundamentals
- 2Risk Management Process Overview
- 3QMS Integration Points
- 4Design & Development Risk Integration
- 5Production Risk Controls
- 6Post-Market Surveillance Feedback
- 7Risk Management File Structure
- 8Common FDA 483 Observations
- 9Documentation Best Practices
Why Organizations Trust This Resource
- Written by an ISO 13485 Lead Auditor
- Covers FDA and EU MDR expectations
- Real-world risk management examples
- Common 483 observations explained
- Risk file documentation templates
Created by Experts
Not generic templates
This resource was developed by a certified Lead Auditor with 25+ years of implementation experience across aerospace, automotive, medical device, and manufacturing industries.
Frequently Asked Questions
Is this applicable for EU MDR compliance?
Yes, this guide covers risk management principles applicable to both FDA and EU MDR requirements. The ISO 14971 framework is recognized globally.
Do I need to buy ISO 14971 separately?
This primer explains the concepts, but you should have access to the actual ISO 14971 standard for your formal documentation. This guide helps you understand and apply it.
Is this suitable for Class I devices?
Yes, risk management is required for all medical device classes. The rigor scales with risk classification, but the principles apply to all devices.
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