ISO 14971:2019 - Risk Management Medical Devices

The harmonised risk management standard. Covers terminology, the risk management process, risk analysis and evaluation, risk control, residual-risk and benefit-risk analysis, and production/post-production information.

Modules

20 modules

Category

Risk Management

Pass mark

80%

Certificate

Free, instant

Audience

Risk managers, design engineers, quality engineers and regulatory professionals.

• Understand foundations of ISO 14971
• Understand risk Analysis and Evaluation
• Understand risk Control, Benefit-Risk and Overall Residual Risk
• Understand risk Management Policy, Plan and File
• Understand risk Analysis Techniques (FMEA, FTA, HAZOP, PHA)
• Understand usability and Use-Related Risk (IEC 62366-1)
• Understand risk Management for Software and AI/ML Devices
• Understand practical Guidance from ISO/TR 24971

• Manage device risk end-to-end

  Apply risk-based thinking across the product life-cycle, from design to post-market surveillance.

• Stay audit-ready

  Understand the exact clauses and expectations auditors and regulators check during inspections.

• Boost your career

  A recognised certificate of completion that you can add to your CV and LinkedIn profile.

• Plain-language modules

  Complex requirements broken into bite-sized, easy-to-remember lessons with examples.

• Free assessment & certificate

  Take the timed exam and earn a personalised, verifiable certificate at no cost.

• Risk managers, design engineers, quality engineers and regulatory professionals

• 20 plain-language modules

  Bite-sized lessons with examples, memory aids and key terms.

• Timed assessment

  Multiple-choice exam with 80% pass mark. Retake anytime.

• Verifiable certificate

  Personalised PDF with a unique verification code — shareable on LinkedIn.

• Downloadable resources

  Reference material and attachments available inside modules.

• Lifetime access

  Learn at your own pace — revisit modules whenever you need to refresh.

• Aligned to standards

  Content mapped to internationally recognised medical device standards and regulations.

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