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Course learning objectives
Learning objectives
Why Risk Management (RM) matters
Evolution of ISO 14971
ISO 14971 and related standards
Key Definition: Hazard
Key Definition: Hazardous Situation
Key Definition: Harm
Key Definition: Risk
The Three H's: Hazard to Harm chain
Key Definition: State of the Art (SoA)
The four core RM documents
The Risk Management File (RMF)
ISO 14971 document hierarchy
The RM process flow
The RM process flow (continued)
The RM process flow (continued)
SAMPLE DEVICE
QUIZ
Learning objectives
RMP purpose and scope
RMP required elements (ISO 14971 Clause 5.2)
RMP scope statement
Risk acceptability criteria
Example: Severity of Harm (SHarm) scale
Example: Probability of Occurrence of Harm (OHarm) scale
Risk Matrix and acceptability
Risk Matrix example
RM team
Hazard identification methods
Review and verification activities
Production and Post-Production activities
QUIZ
Learning objectives
Risk Analysis overview
Risk Analysis vs. Failure Mode and Effects Analysis (FMEA)
Risk Analysis vs. FMEA (continued)
Hazard identification
Hazardous Situation identification
Harm identification
The Three H’s: Hazard, Hazardous Situation, and Harm
Users impacted
Fault Conditions in Risk Analysis
Sequence of Events
Risk Estimation
Probability of Harm: P1 × P2
P1 × P2 Example: Hot Surface
P1 × P2 illustration
Avoid Black Swan events
Risk Control hierarchy
Risk Control implementation
RCM Verification evidence types
Risk Evaluation
Risk = Severity (SHarm) X Occurrence (OHarm)
Analyzing new risks from RCM
Residual Risk Evaluation
Benefit-Risk Analysis
Benefit-Risk Analysis data sources
FDA Benefit-Risk framework
Documenting Benefit-Risk justification
Complete RA Entry components
Significant Residual Risk (SRR)
Significant Residual Risk (SRR) examples
Undesirable Side Effects (EU MDR)
Undesirable Side Effects (EU MDR)
SAMPLE DEVICE
SAMPLE DEVICE - DQS ANSWERS (Part 1)
SAMPLE DEVICE - DQS ANSWERS (Part 2)
SAMPLE DEVICE - DQS ANSWERS (Part 3)
QUIZ
Learning objectives
Class example device: Infant Heel Warmer
Class example device: Infant Heel Warmer - Hazards
Class example device: Infant Heel Warmer – Hazardous Situation
Class example device: Infant Heel Warmer - Harm
Class example device: Infant Heel Warmer - SHarm
Class example device: Infant Heel Warmer - OHarm
Class example device: Infant Heel Warmer - RCMs
Class example device: Infant Heel Warmer – RCM Verification
Class example device: Infant Heel Warmer - Risk
Class example device: Infant Heel Warmer – Residual Risk
Class example device: Infant Heel Warmer – Benefit Risk
Class example device: Infant Heel Warmer – Benefit Risk (continued)
QUIZ
Learning objectives
Why Overall Residual Risk?
ORR evaluation methods
Risk Index calculation
State of the Art (SoA) comparison
ORR Benefit-Risk evaluation
Class example device: Infant Heel Warmer – Benefit Risk for ORR
Disclosure of residual risks
ORR document structure
Writing the ORR conclusion
SAMPLE DEVICE
SAMPLE DEVICE - DQS ANSWERS (Part 1)
SAMPLE DEVICE - DQS ANSWERS (Part 2)
QUIZ
Our SRM course was developed to teach the intricacies of ISO 14971 and to support global product submissions.
Understand the regulatory context, core terminology, and relationship between ISO 14971 and other medical device standards.
Create and maintain Risk Management Plans, Risk Analyses, Overall Residual Risk evaluations, and Risk Management Reviews.
Apply the risk control hierarchy, verify implementation and effectiveness, and document evidence with full traceability.
Evaluate residual risks against medical benefits for risks that cannot be reduced further.
Identify critical tasks from risk analysis Severity (SHarm) ratings and link human factors validation to RCM verification.
Establish PMS systems that feed back into risk management, implement trending programs, and define triggers for RMF updates.
Apply technical writing best practices to create specific, traceable, and defensible risk management documentation.
Introduce related standards (IEC/TR 80002-1, AAMI TIR34971, IEC 80001-1, ANSI/AAMI SW96, EU 2022/2346) to software, AI/ML, networked, security, and non-medical device risk management.
Anticipate auditor expectations, avoid common deficiencies, and demonstrate systematic risk management to regulatory bodies.
