Does this skill support the latest ISO 14971 standards?

Yes, the skill is specifically designed to implement the full ISO 14971 risk management process, including risk analysis, evaluation, control, and post-production monitoring.

Can it help with software-specific medical risks?

Absolutely. It integrates IEC 62304 principles to handle software safety classification (Class A, B, C) and software-specific hazard analysis.

Is this tool suitable for regulatory submission preparation?

Yes, it assists in generating and maintaining the documentation required for the Risk Management File (RMF), which is a critical component of FDA and EU MDR technical files.

How does it handle cybersecurity for connected devices?

The skill includes a dedicated framework for cybersecurity threat modeling, vulnerability assessment, and the implementation of security controls per FDA guidance.

Medical Device Risk Management Specialist

Name: Medical Device Risk Management Specialist
Author: alirezarezvani

byalirezarezvani

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1,039

Security & Testing

Implements ISO 14971 compliant risk management processes across the entire medical device product lifecycle.

About

This skill acts as a senior consultant for medical device development, providing expert guidance on ISO 14971 implementation. It automates hazard identification, risk evaluation, and the creation of comprehensive risk management files, ensuring compliance with international standards like IEC 62304 for software and FDA cybersecurity guidelines. It is an essential tool for engineering and QA teams needing to integrate safety-by-design, verify risk controls, and maintain rigorous documentation for regulatory submissions such as FDA 510(k) or EU MDR.

Key Features

Integration with IEC 62304 for software safety classification
Automated risk matrix calculations and acceptability evaluation
Cybersecurity threat modeling and control implementation
ISO 14971 compliant risk analysis and hazard identification
Comprehensive Risk Management File (RMF) documentation and maintenance
1,039 GitHub stars

Use Cases

Conducting software hazard analysis and risk estimation for IEC 62304 compliance
Updating Risk Management Files based on post-market surveillance data and clinical feedback
Developing a Risk Management Plan for a new Class II or III medical device

About

Key Features

Integration with IEC 62304 for software safety classification
Automated risk matrix calculations and acceptability evaluation
Cybersecurity threat modeling and control implementation
ISO 14971 compliant risk analysis and hazard identification
Comprehensive Risk Management File (RMF) documentation and maintenance
1,039 GitHub stars

Use Cases

Conducting software hazard analysis and risk estimation for IEC 62304 compliance
Updating Risk Management Files based on post-market surveillance data and clinical feedback
Developing a Risk Management Plan for a new Class II or III medical device