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ISO14971:2019 - Verification of implementation and effectiveness of risk control

#1
Hi All

I am trying to implement ISO14971:2019 in our companies risk management procedure and have a question on implementation of risk control measure:

ISO 14971:2019 requires implementation of risk control measures, verification of implementation and verification of the effectiveness of those risk control measures.

Does anyone have any specific examples on how to verify implementation of risk control vs. how to verify effectiveness of the risk controls.

One example i can think of is: for a medical device such as an insulin pen injector; one of the risk control was the OD of pen system to control the dosing of the pen. The implementation of the risk control would then be the drawing and the design verification test protocol. The verification of the risk control would then be the design verification test report .

Can you guys provide other specific examples. For example..if i identify a risk control as Instruction for Use..what would be the verification of implementation and verification of effectiveness for this?

Thank you
 
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yodon

Staff member
Super Moderator
#3
@monoj mon is right - verification confirms the content is included in the IFU and validation (probably via a summative study per 62366) would validate that the instructions were understandable. Bear in mind that if you consider the content deviation from EN ISO 14971:2012 that says labeling alone cannot reduce risk, "effectiveness" is not really a consideration, you just want to be sure that you have communicated in an understandable manner.
 

ThatSinc

Involved In Discussions
#4
look at what the hazardous situation and harm is, and then look at what your control measure is - how can you prove that the control measure has reduced the probability of the hazardous situation or harm from occurring.

some abbreviated potentials below from previous experience;

Risk/Issue - Control Measure - VoE
Device damaged in transit - Robust shipping boxes - transit validation
Device degrades over time (fluid in a bottle) - device formulation for long shelf life / packaging size to ensure it's used in a timely manner - stability studies for life / validation on time taken for users to exhaust a bottle following opening
Skin sensitivity to device - product formulation - ISO 10993 mandated studies on sentisation etc.


@monoj mon Bear in mind that if you consider the content deviation from EN ISO 14971:2012 that says labeling alone cannot reduce risk, "effectiveness" is not really a consideration, you just want to be sure that you have communicated in an understandable manner.
I thought that this myth was debunked a long time ago?

Instructions for safety and disclosure of residual risk are two completely separate entities.

Putting a warning on a UV lamp that says "Exposure to UV may cause skin cancer" does not reduce risk. Providing an instruction that users must wear appropriate safety equipment, etc. If shown to be understood, and verified as effective through any usability studies, certainly can reduce the risk.
 
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