ISO 14971 Risk Management guidance for Startups

This is your complete masterclass in risk management implementation for medical devices.

We will go clause-by-clause, example-by-example, from concept to complaint handling, to ensure your team knows how to apply ISO 14971 in real projects.

We’ll cover:

• Step-by-step RMF creation — from hazard identification to benefit-risk analysis.
• How to link risk management with design control, verification, and CAPA.
• Creating your own risk matrix and templates for FMEA and risk evaluation.
• Integration with PMS, Vigilance, and Clinical Evaluation as per IMDR 2017 and MDR 2017.
• How to prepare for auditor questions on ISO 14971 evidence.

Value to your company:

You’ll walk away with ready-to-use templates, structured processes, and a complete understanding of what makes a compliant RMF.

This session turns your QA and R&D teams into risk-thinking professionals, improving patient safety, regulatory compliance, and brand credibility.