🔗 Part of the Regulatory Framework

ISO 14971 is aligned with global regulatory requirements, including:

• EU MDR and IVDR

• US FDA QMSR (Quality Management System Regulation)

• IMDRF and GHTF guidelines
  
  

It is also often integrated with ISO 13485 (QMS for medical devices) and forms the backbone of any compliant device development process.

🛡️ Core Principles of ISO 14971

While ISO 14971 is not built around the 7 QMS principles like ISO 9001, its own structured risk management framework revolves around:

1. 🕵️ Risk Analysis

Identify potential hazards and their sources at every stage—from raw materials to end use.

Optimize helps with:

• Hazard identification templates

• Clinical use risk brainstorming sessions

2. 📊 Risk Evaluation

Estimate the probability of occurrence and the severity of harm.

We provide:

• Risk matrices customized to your product

• Criteria alignment with regulatory expectations
  
  

3. 🔧 Risk Control

Implement design changes or protective measures to reduce unacceptable risks.

Our experts assist in:

• Control measure design

• Residual risk acceptability justification
  
  

4. 🧪 Evaluation of Overall Residual Risk

Are the remaining risks acceptable when taken together? Are the benefits worth it?

Optimize facilitates:

• Benefit-risk assessments

• Clinical input integration
  
  

5. 🔁 Risk Review and Post-Market Monitoring

Keep your risk management system alive and relevant through product updates and market feedback.

We help with:

• Post-market surveillance plans

• CAPA integration
  
  

🌟 Benefits of ISO 14971 Implementation

•  Stronger product safety and reliability

•  Faster regulatory approval and fewer delays

•  Better clinical decision alignment

•  Reduced liability and product recall risk

•  Increased trust with customers and regulators

🛠️ How Optimize Supports ISO 14971 Compliance

We guide your team from concept to compliance with:

📋 Risk Management File Preparation
🧠 Risk Assessment Training Workshops
🛠️ Integration with Design Controls and QMS
📈 Post-market Risk Strategy & Feedback Loops
🔍 Audit Readiness and Documentation Support

💼 GET THE MOST FROM YOUR RISK MANAGEMENT SYSTEM

ISO 14971 isn’t just about documentation—it’s a mindset that protects lives and secures your product’s place in the market.

With Optimize, you’ll:

• Build risk culture into your design and development

• Avoid costly rework and nonconformities

• Increase confidence in product launch and approval

📞 Partner With Optimize for Safe, Compliant Innovation

Whether you’re preparing for CE marking, FDA clearance, or internal compliance—ISO 14971 helps you manage risk with clarity and control.

💡 At Optimize, we make complex compliance simple.

✅ Personalized guidance
✅ Domain expertise in healthcare and devices
✅ Affordable, end-to-end packages

✨ Talk to us today—protect your product, protect your patients.

Reach out to Optimize and start your ISO 14971 journey today.