Hello Beth,
To add on what Dan said, this should be a continuous process. Checking effectiveness of the safety information looks at customer feedback, customer complaints, and how the product is being used in clinical application. While usability testing is good, often this is still in a "controlled" environment where it is being used as input into the information for the user and risk assessment. The effectiveness of safety can be confirmed and/or updated through information gained from the field and use of the device - this can then be used to update the risk management file and instructions for use, as appropriate.
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Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 30-Apr-2023 16:49
From: Dan O'Leary
Subject: ISO 14971:2019 - verification of effectiveness of risk control measures
The basic concept comes from IEC 62366-1:2015+AMD1:2020, 4.1.3 on usability engineering. Information for safety should be perceivable, understandable, and support correct use of the device.
There are a few standard methods. One uses a "label" from a standard. The label may have a symbol, wording, colors, size, etc. depending on the standard. Document the source of label, by standard number, revision, clause, etc.
Another uses a sample of users. If the label is on the device, you might ask a sample of users to explain what it means. If the label is in the IFU, there is usually some statement or description. You might ask the sample of users some relevant question and ask them to answer it using the IFU. I recently did this with a client who makes a device associated with diagnostic imaging scanners. We asked them to find the information about the MR safety of the device and to explain the MR safety label on the device.<o:p></o:p>
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Dan O'Leary CQA, CQE
Swanzey NH
United States
Original Message:
Sent: 30-Apr-2023 16:00
From: Beth Gordon
Subject: ISO 14971:2019 - verification of effectiveness of risk control measures
Hi there,
ISO 14971:2019 Clause 7.2 calls for verification of effectiveness of risk control measures. This is quite straight-forward for inherent safety or protective measures, but I'm wondering what approaches people take to verify the effectiveness of safety information?
Thanks!
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Beth Gordon
Systems Manager
Christchurch
New Zealand
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