Risk control measures as per ISO 14971

Regulatory

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#1
Hi guys!!
I have one doubt regarding control measures as per EN ISO 14971:2012.. According to this we can not use Information on safety (i.e. Labels on equipment, Training to user or Instruction for use) as a control measures to reduce the risk.. but there are some risk for which we can't give any interlock feature (safety by design) or protective measures for example:
1- safe disposal of device- for this we can only guide the user and give the disposal way in accompanying documents..
2- Servicing and maintenance- only company authorized person is allowed for the servicing and maintenance and this information convey to user through training and accompanying documents.
3- Storage and operation of device, outside the prescribed environmental condition- provide the information to user through pasting a label on equipment, training to user and mentioned in accompanying documents.

like above, have other risk also.. please help me out to overcome the such type of problems.. any interlocking features or protective measures is possible for above mentioned risk ?? If possible please guide or if not possible please advice what should we do to convince the auditor..

Thanks a lot!!
 
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Developer_Germany

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#2
Please see
www(.)team-nb.org/wp-content/uploads/2015/05/nbmeddocuments/NBRG_WG%20RM_Interim_NBmed_Consensus_Version_140812_1_1(.)pdf

In Content deviation 7 help on that topic is given for Europe's interpretation. Use it as it is written by EU auditors.

Information on how to avoid harm is considered as risk control. Information about residual risk is considered to be NO risk control.
 
#3
You will always have some hazards that you won't be able to control fully, which you can only disclose as residual risks. The examples mentioned by you could absolutely fall under this category, but don't have to, at least not all.

Depending on the situation and device, one *could* make inappropriate storage conditions discoverable by implementing a climate sensitive control function that will render the device inoperable if stored incorrectly, or warn the user that inappropriate storage was detected (color/humidity sensitive dyes?). If your device is measuring something (e.g. in an IVD device), you could implement some sort of storage-sensitive internal control that needs to be picked up alongside the actual measurand for generating a valid result.

If your device is controlled by software, there could be a servicing account that only authorised personnel has access to.

Then, you also need to keep in mind that information for safety can come in different flavors - written instructions may very well be able to reduce risk, if you can demonstrate, e.g. through usability studies, that they reduce the occurrence of use errors. As Developer_Germany stated,
information on how to avoid harm is considered as risk control.
 

Regulatory

Involved In Discussions
#4
Please see
www(.)team-nb.org/wp-content/uploads/2015/05/nbmeddocuments/NBRG_WG%20RM_Interim_NBmed_Consensus_Version_140812_1_1(.)pdf

In Content deviation 7 help on that topic is given for Europe's interpretation. Use it as it is written by EU auditors.

Information on how to avoid harm is considered as risk control. Information about residual risk is considered to be NO risk control.
Thanks a lot but please send the attachment of above said link because this link is not open (Error!! 404, page not found shown..)
 

Regulatory

Involved In Discussions
#7
You will always have some hazards that you won't be able to control fully, which you can only disclose as residual risks. The examples mentioned by you could absolutely fall under this category, but don't have to, at least not all.

Depending on the situation and device, one *could* make inappropriate storage conditions discoverable by implementing a climate sensitive control function that will render the device inoperable if stored incorrectly, or warn the user that inappropriate storage was detected (color/humidity sensitive dyes?). If your device is measuring something (e.g. in an IVD device), you could implement some sort of storage-sensitive internal control that needs to be picked up alongside the actual measurand for generating a valid result.

If your device is controlled by software, there could be a servicing account that only authorised personnel has access to.

Then, you also need to keep in mind that information for safety can come in different flavors - written instructions may very well be able to reduce risk, if you can demonstrate, e.g. through usability studies, that they reduce the occurrence of use errors. As Developer_Germany stated,
Thanks for the guidance, it would be helpful for me..
 
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