Course Description

The Audit Defense Series

Risk Management Made Simple: A Lean ISO 14971 Strategy

Stop fearing the spreadsheet. Start protecting your patients. Is your Risk Management File only updated two days before an audit? This course is designed to dismantle the heavy bureaucracy typically associated with medical device risk assessment. Part of The Audit Defense Series, this masterclass gives quality and regulatory professionals a streamlined, tactical approach to the ISO 14971:2019 framework, shifting the focus from paper compliance to actual product safety.

Course Outlines

Risk Management Made Simple

DROWNING IN COMPLEX ISO 14971 SPREADSHEETS?

Is your Risk Management File a mountain of confusing data that only gets updated days before an audit? It is time to cut the academic bloat and start using it as a streamlined safety tool!

Designed specifically for non-engineers who need strict compliance without the administrative headaches:

RISK MANAGEMENT MADE SIMPLE: A Lean ISO 14971 Strategy

What you will learn:

• The "Spirit" Over Math - Finally understand risk management concepts without getting lost in overly complicated formulas.

• The 3-Step Lean Matrix - Master 5x5 or 3x3 matrices to map out acceptability criteria with zero fluff.

• Hazard Identification - Easily brainstorm and pinpoint technical, biological, and "use-error" hazards.

• Smart Risk Control - Implement the Hierarchy of Control and confidently document Benefit-Risk Analyses.

• Seamless PMS Linking - Keep your Risk File "alive" by updating it effortlessly based on post-market customer complaints.

Protect your patients. Protect your business. Keep it lean. Click below to view the full course outline and secure early bird pricing!

For urgent inquiries, please contact our hotline at 011 6335 8577 | 011 6334 8577