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        • T-013-001 Risk management plan
        • T-013-002 Risk management record_YYYY_nnn
        • T-013-003 Risk management report
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  • T-013-003 Risk management report

T-013-003 Risk management report

Intended use and identification of the qualitative and quantitative characteristics​

The following questions, extracted from Annex A.2 of UNE-CEN ISO/TR 24971:2020, help us identifying all the characteristics of the medical device manufactured that could affect its safety and performance. The list is neither exhaustive nor representative and must be appropriate to the medical device in question, and we will skip the questions that are not relevant to it.

#Characteristics of the medical device that could affect safetyApplicable? (Y/N)JustificationRisk identified
1What is the intended use and how is the medical device to be used?
2Is the medical device intended to be implanted?
3Is the medical device intended to be in contact with the patient or other persons?
4What materials or components are utilized in the medical device or are used with, or are in contact with, the medical device?
5Is energy delivered to or extracted from the patient?
6Are substances delivered to or extracted from the patient?
7Are biological materials processed by the medical device for subsequent reuse, transfusion or transplantation?
8Is the medical device supplied sterile or intended to be sterilized by the user, or are other microbiological controls applicable?
9Is the medical device intended to be routinely cleaned and disinfected by the user?
10Does the medical device modify the patient environment?
11Are measurements taken?
12Is the medical device interpretative?
13Is the medical device intended for use in conjunction with other medical devices, medicines or other medical technologies?
14Are there unwanted outputs of energy or substances?
15Is the medical device susceptible to environmental influences?
16Does the medical device influence the environment?
17Does the medical device require consumables or accessories?
18Is maintenance or calibration necessary?
19Does the medical device contain software?
20Does the medical device allow access to information?
21Does the medical device store data critical to patient care?
22Does the medical device have a restricted shelf life?
23Are there any delayed or long-term use effects?
24To what mechanical forces will the medical device be subjected?
25What determines the lifetime of the medical device?
26Is the medical device intended for single use?
27Is safe decommissioning or disposal of the medical device necessary?
28Does the installation or use of the medical device require special training or special skills?
29How will information for safety be provided?
30Are new manufacturing processes established or introduced?
31Is successful application of the medical device dependent on the usability of the user interface?
31.1Can the user interface design features contribute to use error?
31.2Is the medical device used in an environment where distractions can cause use error?
31.3Does the medical device have connecting parts or accessories?
31.4Does the medical device have a control interface?
31.5Does the medical device display information?
31.6Is the medical device controlled by a menu?
31.7Is the successful use of the medical device dependent on a user’s knowledge, skills and abilities?
31.8Will the medical device be used by persons with special needs?
31.9Can the user interface be used to initiate unauthorised actions?
32Does the medical device include an alarm system?
33In what ways could the medical device be misused (deliberately or not)?
34Is the medical device intended to be mobile or portable?
35Does the use of the medical device depend on essential performance?
36Does the medical device have a degree of autonomy?
37Does the medical device produce an output that is used as an input in determining clinical action?

List of generic hazards applicable to this product family​

Associated with energy sourcesApplicable (Y/N)Justification
Electricity
Heat, surface temperature
Mechanical strength
Ionizing radiation
Electromagnetic fields
Moving parts (motorized)
Suspended masses
Failure of patient support system
Pressure
Sound pressure (noise)
Vibrations
Magnetic fields
BiologicalApplicable (Y/N)Justification
Biological overload
Incorrect release of substances or energy
Incorrect formulation (chemical composition)
Biocompatibility and toxicity
Infection and biological contamination
Difficulty in maintaining hygienic safety
Degradation
Associated with the environmentApplicable (Y/N)Justification
Electromagnetic interference
Inadequate supply of energy or cold
Restriction of ventilation, perspiration
Probability of operation in adverse environmental conditions
Incompatibility with other devices
Accidental mechanical damage to the product
Pollution (waste and removal)
Corrosion
Flammability
Relative to the use of the productApplicable (Y/N)Justification
Inadequate label
Inadequate instructions for use
Inadequate specification of accessories
Inadequate specification of pre-use checks
Complicated instructions for use
Instructions for use not available or separate from the product
Use by untrained personnel
Reasonably foreseeable misuse
Inadequate warning of adverse effects
Inadequate warning of possible hazards in case of reuse of single-use products
Incorrect measurement and other metrological aspects
Incorrect diagnosis
Wrong data transfer
Misinterpretation of results
Incompatibility with consumables, accessories or other devices
Forces, inadequate contact pressures
Imprisonment of parts of the human body
Non-functional edges, surfaces or cutting edges
Discomfort of use and handling (ergonomics)
Associated with functional failure, maintenance and aging of the productApplicable (Y/N)Justification
Inadequate to the planned functions
Inadequate or absent maintenance specifications, including performance checks
Inadequate maintenance
Absence of limitation of product lifetime
Loss of mechanical integrity
Inappropriate packaging (loss of sterility, contamination or deterioration of the product)
Incorrect reuse
Cutting edges due to breakage

Benefit/Risk ratio acceptability​

The benefit/risk analysis is based on global and individual risks considerations:

  • Global: it is assessed in consideration of the product features and its T-015-003 Clinical evaluation report (CER). Global benefit/risk ratio is acceptable, according to the CER conclusions: TO INCLUDE

  • Individual: when a risk is evaluated as “ALARP” it requires minimization measures of the residual risks. The following risks have been evaluated as "ALARP":TO INCLUDE

note

If measures to minimize residual risks considered "“ALARP”" have not been implanted, it will be required a specific analysis on the T-013-002 Risk Management Record, being the benefit/risk ratio unacceptable during this evaluation until it is acceptable.

Control state of the risks​

The current state of risks control verifies that ALL FORESEEABLE RISKS ARE CONTROLLED according to T-013-002 Risk Management Record Include version/date.

All risks are in an acceptable risk zone, but the individual risks mentioned below, are defined as AFAP risk level.

Hazard #Hazard and hazardous situationAdditional control measures
#
#
#
#
#
#

These risks require an individual benefit/risk analysis which is conducted as specified at the T-013-001 Risk management plan, and it is confirmed by the global benefit/risk ratio analysis performed and documented at the T-015-003 Clinical evaluation report (CER). All of them are currently controlled, but PMS and PMCF data will confirm a minimization.

Record signature meaning​

  • Author: JD-004 Author name
  • Review: JD-003 Reviewer name
  • Approval: JD-005 Approver name

Template signature meaning​

info

Delete this section when you create a new record from this template.

  • Author: JD-004 María Diez
  • Review: JD-005 Mr. Alfonso Medela
  • Approval: JD-001 Andy Aguilar
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GP-014 Feedback and complaints
  • Intended use and identification of the qualitative and quantitative characteristics
  • List of generic hazards applicable to this product family
  • Benefit/Risk ratio acceptability
  • Control state of the risks
  • Record signature meaning
  • Template signature meaning
All the information contained in this QMS is confidential. The recipient agrees not to transmit or reproduce the information, neither by himself nor by third parties, through whichever means, without obtaining the prior written permission of Legit.Health (AI LABS GROUP S.L.)