Risk control measures as per ISO 14971

Regulatory

Starting to get Involved
#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!!
 
Elsmar Forum Sponsor

Developer_Germany

Starting to get Involved
#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

Starting to get Involved
#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

Starting to get Involved
#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..
 
Thread starter Similar threads Forum Replies Date
A 5.5.3 - Software Unit Acceptance Criteria (Risk Control Measures) IEC 62304 - Medical Device Software Life Cycle Processes 3
A Effectiveness of Risk Control Measures ISO 14971 - Medical Device Risk Management 4
M Control Measures for Hazards already deemed Low Risk ISO 14971 - Medical Device Risk Management 6
M ISO 14971:2012 - Verification of Implementation of Risk Control Measures ISO 14971 - Medical Device Risk Management 12
M ISO14971:2019 - Verification of implementation and effectiveness of risk control ISO 14971 - Medical Device Risk Management 3
adir88 Documenting Risk Control Option Analysis ISO 14971 - Medical Device Risk Management 8
D IEC 62304 Risk Classification - With and without hardware control IEC 62304 - Medical Device Software Life Cycle Processes 2
D Performance specification as a Risk Control Measure, EN 14971 ISO 14971 - Medical Device Risk Management 7
Ashok sunder Is it possible to reduce Risk likelihood and impact Post control Ranking after corrective action taken for risk? FMEA and Control Plans 1
D Software as risk control - Confused on one aspect of IEC 62304 IEC 62304 - Medical Device Software Life Cycle Processes 20
qualprod ISO 9001 Risk control method - What could be the better way to control risks? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
M Can Scope of Equipment Control be Tied to Risk? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
Y Training as a risk control for ISO 14971 ISO 14971 - Medical Device Risk Management 13
Q How to Analyze Risk if is out of your control ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
F Medical Device HACCP (Hazard Analysis and Critical Control Point) Risk Management ISO 14971 - Medical Device Risk Management 2
Y Risk Control Implemented in Software IEC 60601 - Medical Electrical Equipment Safety Standards Series 6
K Risk Reduction by Risk Control: IEC:62304-Class C ISO 14971 - Medical Device Risk Management 15
Q Applying Risk to the Medical Device Document Control Program Document Control Systems, Procedures, Forms and Templates 3
S What to do if no further control possible to reduce the OHS risk? Occupational Health & Safety Management Standards 16
S What does "Operational Review" mean as tool - Effectiveness of Internal Control Risk Management Review Meetings and related Processes 3
S Risk Management and Revision Control ISO 14971 - Medical Device Risk Management 1
Marc Millions of Ford vehicles have fire risk part - Cruise-control deactivation switch World News 0
A Maturity Model of Organisations - Administrative Risk Control And CI Misc. Quality Assurance and Business Systems Related Topics 0
G Risk of stopping your customer's line IATF 16949 - Automotive Quality Systems Standard 0
C Risk Matrix vs FMEAs ISO 14971 - Medical Device Risk Management 3
S IVD risk class II devices for Brazil and MDSAP Other Medical Device Regulations World-Wide 0
M ISO 14971:2019: Criteria for overall residual risk ISO 14971 - Medical Device Risk Management 3
Aymaneh Medical Device Cybersecurity Risk Management IEC 27001 - Information Security Management Systems (ISMS) 2
S Traceability of requirements to design and risk Design and Development of Products and Processes 3
D Deciding whether or not pre-market clinical investigation is required for low risk device EU Medical Device Regulations 5
R The term "Benefit Risk Ratio" in EU MDR, do I need to present benefit risk analysis as a RATIO Risk Management Principles and Generic Guidelines 4
_robinsingh Security Risk Assessment Tool IEC 27001 - Information Security Management Systems (ISMS) 0
A 21 CFR 820 - Risk Management - Looking for some guidance US Food and Drug Administration (FDA) 3
bryan willemot Contract Review and risk managment AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
D Risk Analysis using Monte Carlo Simulation instead of Scoring and Heat Map Risk Management Principles and Generic Guidelines 2
Sravan Manchikanti Software Risk Management & probability of occurrence as per IEC 62304 IEC 62304 - Medical Device Software Life Cycle Processes 8
E Normal Condition Hazards in Risk Analysis ISO 14971 - Medical Device Risk Management 3
silentmonkey Rationalising the level of effort and depth of software validation based on risk ISO 13485:2016 - Medical Device Quality Management Systems 10
R Risk assessment on IT containers and the information they contain IEC 27001 - Information Security Management Systems (ISMS) 4
B Threat/Vulnerability Catalogue for risk assessment IEC 27001 - Information Security Management Systems (ISMS) 4
R Opportunity For Improvement vs Opportunity (Positive Risk) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 18
R FOD Risk Assessment - What tools would you recommend for assessing FOD risk? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
R Identify Medical Device characterstics as Annex C of ISO 14971 Risk Management ISO 14971 - Medical Device Risk Management 5
A ISO 14971 PFMEA Manufacturing Risk ISO 14971 - Medical Device Risk Management 2
Q Example of the Risk Template Document Control Systems, Procedures, Forms and Templates 1
K Overall residual risk according to ISO 14971:2019 ISO 14971 - Medical Device Risk Management 5
A Risk Number for each software requirement IEC 62304 - Medical Device Software Life Cycle Processes 7
A IEC 60601 11.2.2.1 Risk of Fire in an Oxygen Rich Environment, Source of Ignition IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
D Importing a general wellness low risk product Other US Medical Device Regulations 3
C Quantifying risk in choosing the number of parts, operators and replicates in a GR&R Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 4

Similar threads

Top Bottom