ISO 14971: 2019 Overview

Risk management is the spine of every safe medical device.

This session gives you a complete understanding of ISO 14971:2019, the global framework for risk management in medical devices.

You’ll learn:

• What ISO 14971 really expects from manufacturers.
• The risk management process – identification, analysis, evaluation, control, and post-market monitoring.
• Creating and maintaining a Risk Management File (RMF).
• Linking risk control to design inputs, verification, and validation.
• Integration of usability, biocompatibility, and cybersecurity risks.

Value to your company:

Once you understand ISO 14971, you will never look at product safety the same way again.

Your design and QA teams will start thinking proactively about risk, which is the biggest differentiator in audit success and global market approval.

This is not an optional session — it’s your ticket to building devices that are safe, compliant, and globally acceptable.