How to Apply AI Risk Prompts to Real-World Medical Device Development

Effective risk assessment is a foundation of compliant and safe medical device development. If you’ve downloaded our free guide with expert-level ChatGPT prompts, you've already made a strategic move toward improving your risk management processes.

Now it's time to translate those AI-generated insights into practical, real-world actions — grounded in standards like ISO 14971, IEC 60601, and FDA guidelines.

❗ Haven’t downloaded the prompt guide yet? Download it here to unlock professional-level AI prompts for medical device risk management.

What You’ll Learn in This Article:

• How to structure high-quality prompts that generate actionable answers

• How to link hazard logs and prompts for better traceability and compliance

• How to apply real-life examples to your product development and risk mitigation strategy

1. How to Write Prompts That Actually Work

AI tools like ChatGPT are only as good as the questions you ask. Effective prompts for medical device risk analysis should be:

• Problem-specific – What exact risk are you evaluating?

• Environment-specific – Is the device for clinical, home, or mobile use?

• Scenario-based – What are the conditions under which failure could occur?

Example Prompt:
"What factors could lead to sensor failure during long-term ICU use, and how can these be mitigated according to ISO 14971?"

Why it works: It combines device context, clinical environment, and a clear connection to regulatory standards.

Want to avoid common mistakes in risk strategy?
Read: Hidden Pitfalls in the Risk Management Strategy by Charles Bradanov
It explains why even well-intended plans fail — and how ISO 14971-based tools like qmsWrapper can help.

2. Connect Prompts with Your Hazard Log

Your hazard log isn’t just for audits — it’s your blueprint for safe product development. Use each hazard as a foundation for targeted AI queries:

• Map hazards to regulatory clauses (e.g., Annex C of ISO 14971)

• Develop prompts to explore root causes and controls

• Include design inputs that support early mitigation

Example Prompt:
"How can short circuits in sensor leads be prevented in high-humidity environments common to tropical field hospitals?"

This creates traceable documentation that links risk evaluation with design and usability requirements.

3. Try This Real-World Scenario

Imagine you're developing a wearable cardiac monitor. One potential risk: inaccurate readings during physical activity.

Prompt Example:
"What conditions might cause inaccurate heart rate readings during vigorous exercise, and how can the device design or algorithm be improved to ensure accuracy?"

This type of prompt helps uncover design flaws, algorithmic gaps, and environmental factors — making your risk control measures more robust.

Why This Matters

Creating precise, context-rich prompts and pairing them with a structured hazard log creates:

• Clear traceability for audits

• Stronger regulatory alignment

• Smarter, faster design decisions

When used consistently, this approach supports continuous improvement in your risk management system and aligns with the principles of ISO 14971 risk-based thinking.

What’s Next?

Leverage your prompt guide and start building AI-assisted workflows that strengthen your QMS and product safety. AI doesn’t replace expertise — it extends it.