ClawTrust
8.4
/ 10
1 evaluations
2.8k Downloads
Overview
Implements a structured ISO 14971:2019 risk management process for medical devices across the full product lifecycle, including planning, analysis, evaluation, control, and post‑production monitoring.
Key Advantages
1.End-to-end coverage of the ISO 14971 risk management process, from initial planning to post‑market surveillance.
2.Provides concrete workflows, checklists, templates, and decision trees that reduce ambiguity and improve consistency of risk activities.
3.Built around a clear 5×5 risk matrix with defined probability and severity scales, aligned with typical ISO 14971 practices.
4.Explicitly incorporates ALARP reasoning, benefit‑risk analysis triggers, and a hierarchy of risk controls (inherent safety → protective measures → information for safety).
5.Includes tooling support (e.g., risk_matrix_calculator.py) for calculating risk levels and FMEA RPN with structured, machine‑readable output (JSON).
Use Cases
- Designing and documenting a complete ISO 14971-compliant risk management plan for a new medical device.
- Conducting systematic hazard identification and risk analysis (e.g., FMEA, FTA, HAZOP, use error analysis) for hardware, software, and usability aspects.
- Evaluating identified risks against predefined acceptability criteria and determining where risk controls or benefit‑risk justifications are required.
- Defining and selecting appropriate risk control measures, verifying their effectiveness, and reassessing residual risk.
- Setting up and maintaining post‑production risk management processes, including complaint trending, vigilance input, and periodic risk reviews aligned with ISO 14971 and ISO 13485 processes.
Evaluation Scores
8.4
/ 10
Reliability
8.0
Functionality
9.0
Usability
9.0
Safety
7.5
Performance
8.0
Compatibility
8.5
Based on 1 evaluation · Latest: 3/19/2026
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Evaluation History (1)
8.4/103/19/2026▼
OS: darwin-x64LLM: stepfun/step-3.5-flash
**Quick judgment**
A strong, well-structured specialist skill for ISO 14971:2019 risk management on medical devices. It is best suited for RA/QA, design, and clinical teams that already understand basic regulatory concepts and need a systematic, documented process rather than ad‑hoc risk tables.
**What it does well**
- Covers the full ISO 14971 lifecycle: planning, analysis, evaluation, control, residual risk, and post‑production surveillance.
- Provides clear workflows, matrices, checklists, decision trees, and templates that can be translated directly into procedures and records.
- Incorporates common industry methods (FMEA, FTA, HAZOP, use error analysis) and a clear 5×5 risk matrix with defined P/S scales and ALARP guidance.
- Supports integration with related quality/regulatory skills (ISO 13485 QMS, CAPA, regulatory submissions, documentation management).
**Key risks / limitations**
- Does not by itself guarantee regulatory compliance; notified body or authority expectations (e.g., EU MDR, FDA) and company‑specific procedures still need to be applied.
- Probability/severity bands and ALARP framing may require tailoring to your organization’s risk policy and to particular device categories.
- As with any AI-driven tool, there is a risk of missed or misprioritized hazards if domain experts do not critically review the outputs.
- Not ideal for non‑medical products or for teams with no prior exposure to risk management or regulatory concepts.
**Recommended scenarios**
- Startups or SMEs developing medical devices that need to stand up an ISO 14971-aligned process with structured documentation quickly.
- Established manufacturers wanting to standardize and digitize their risk management workflows and records.
- Cross‑functional design reviews where engineering, clinical, usability, and quality teams need a shared, systematic risk framework.
- Training and onboarding of new RA/QA or design engineers into ISO 14971 concepts using practical, workflow‑oriented guidance.
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