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Training InsideTheCore
17
Provide by the Team
RISK MANAGEMENT
ISO 14971
CHAPTERS
1. Definitions
2. Risk Management Plan
3. Risk Analysis
4. Risk Management Report
5. Examples
6. And After
DEFINITIONS FROM ISO14971
HAZARD – potential source of harm
HARM – physical injury or damage to the health of people, or damage to property or the environment
RISK – combination of the probability of occurrence of harm and the severity of that harm
RISK EVALUATION – process of comparing the estimated risk against given risk criteria to determine the acceptability of the risk
RISK CONTROL – process in which decisions are made and measures implemented by which risks are reduced to, or maintained within, specified levels
RESIDUAL RISK – risk remaining after risk control measures have been taken
CHAPTERS
CHAPTERS
1. Scope
2. Terms and conditions
3. General requirements for risk management (Plan)
4. Risk analysis
5. Risk evaluation
6. Risk control
7. Evaluation of overall risk acceptability
8. Risk management report
9. Production and post-production information
ANNEXES
ANNEXES
• Annex A – Rationale for requirements
• Annex B – Overview of risk management process for medical devices
• Annex C – Questions that can be used to identify MD characteristics that could impact safety
• Annex D – Risk concepts applied to medical devices
• Annex E – Examples of hazards, foreseeable sequences of events, and hazardous situations
• Annex F – Risk management plan
• Annex G – Information on risk management techniques
• Annex H – Guidance on risk management for in-vitro diagnostic medical devices
• Annex I – Guidance on risk analysis process for biological hazards
• Annex J – Information for safety and information about residual risk
MDR
Medical Device Regulation
• Annex 1 - GSPR
1. ... acceptable risks when weighed against the benefits ...
2. ... reduction of risks as far as possible ...
3. Manufacturers shall establish, implement, document and maintain a risk management system
4. To reduce risks, Manufacturers shall manage risks so that the residual risk associated with each hazard as well as the overall residual risk is judged acceptable.
4. Manufacturers shall inform users of any residual risks.
5. ... reduce as far as possible the risks related to the ergonomic features of the device and the environment in which the device is intended to be used.
PLAN YOUR RISK MANAGEMENT
According to Plan
Conclusion
Appropriate Methods
Which Device
Who
Criteriums
RISK MANAGEMENT
RISK ANALYSIS
RISK ANALYSIS
2. Define hazardeous situation and potential harm
1. Identifying the Hazards = potential source of harm
See Annexe C of ISO14971
RISK ESTIMATION
RISK EVALUATION
What is the probability that a guy will enter the room carrying a gas canister ?
What will happen to this guy ?
RISK ASSESSMENT
RISK EVALUATION
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Competitor C Name
Strengths
Weaknesses
RISK CONTROL
RISK CONTROL
OVERALL RISK ANALYSIS
The next step is to now evaluate the overall residual risk acceptability of the medical device on its whole entirety.
IF acceptable --> Risk Management REPORT
IF not acceptable --> PERFORM a new Risk Analysis
Examples (Good or Bad)
Discuss together the following exercises.
Risk Analysis
RISK ESTIMATION
Risk Analysis
RISK ESTIMATION
Risk Analysis
RISK ESTIMATION
Risk Evaluation
RISK ANALYSIS