Does this skill support ISO 14971 compliance?

Yes, it is specifically designed to implement the full ISO 14971 risk management process, including planning, analysis, evaluation, and control.

Does it provide templates for risk documentation?

Yes, it includes assets for Risk Management Plans, standardized Risk Matrices, and Hazard Libraries to accelerate documentation.

How does it address medical device cybersecurity?

It follows FDA guidance to implement cybersecurity threat modeling, vulnerability assessment, and the implementation of preventive and detective controls.

Can it handle software-specific medical device risks?

Absolutely. It integrates IEC 62304 standards for software safety classification (Class A, B, C) and identifies software-specific failure modes.

Senior Risk Management Specialist

Name: Senior Risk Management Specialist
Author: pur3v4d3r

bypur3v4d3r

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セキュリティとテスト

Implements ISO 14971-compliant risk management processes for medical devices, covering hazard identification, risk evaluation, and post-production monitoring.

概要

This skill acts as a senior consultant for medical device risk management, facilitating full compliance with ISO 14971 throughout the product lifecycle. It provides expert guidance on risk analysis, hazard identification across hardware and software (IEC 62304), and the implementation of hierarchical risk controls. Users can leverage this skill to establish Risk Management Plans, perform cybersecurity threat modeling, conduct human factors use-error analysis, and maintain a comprehensive Risk Management File (RMF) that satisfies regulatory requirements for FDA and EU MDR submissions.

主な機能

Hazard identification for hardware, software, and cybersecurity assets
Integration with IEC 62304 for software safety classification
Automated risk matrix calculation and post-market information analysis
1 GitHub stars
ISO 14971 framework implementation and RMF maintenance
Hierarchical risk control implementation and verification tracking

ユースケース

Developing a comprehensive Risk Management Plan for a new medical device development project
Automating the maintenance of Risk Management Files using provided assessment scripts
Conducting a cybersecurity threat model and risk assessment for connected medical devices

概要

主な機能

Hazard identification for hardware, software, and cybersecurity assets
Integration with IEC 62304 for software safety classification
Automated risk matrix calculation and post-market information analysis
1 GitHub stars
ISO 14971 framework implementation and RMF maintenance
Hierarchical risk control implementation and verification tracking

ユースケース

Developing a comprehensive Risk Management Plan for a new medical device development project
Automating the maintenance of Risk Management Files using provided assessment scripts
Conducting a cybersecurity threat model and risk assessment for connected medical devices