01 Risk Management Report

Risk Management Report
Controlled No. □ Controlled ( ) □ Uncontrolled
Distribution
Applied Standard : EN ISO14971(2012)

Product Name : Orthodontic Ceramic Bracket
Brand Name : VENUS Bracket & ROSE Bracket & ROSA Bracket
Model Name : Total 600 models including VAR-18-11 Venus-A Bracket Roth018 #11
Document No. : GNI-RMR-001
Revision Date : 2018.05.23
Revision No. : Rev. 2
Department/Title Name Date Signature
Sales & Quality Team /

Issue Manager Jung Hyun, Lee 2018.05.23
Quality Management
Review Representative Young Kyun, Kim 2018.05.23
Approval President Dug Soo, Kim 2018.05.23

Risk Management Report Revision No. : Rev. 2
Orthodontic Ceramic Bracket Revision Date : 2018.05.23
[VENUS Bracket, ROSE Bracket, ROSA Bracket] Page : 2 of 34
[Revision History]
Rev. No. Revision Date Reasons of Revision
0 2017.08.22 Newly established
1 2018.02.07 Revised due to corrective action of CE Audit
2 2018.05.23 Revised due to corrective action of CE Audit
10
<Contents>
1.0 Purpose ······································································································································································································································································· 4
2.0 Terms and definitions ············································································································································································································································· 4
3.0 General requirements for risk management ···································································································································································································· 8
3.1 Risk Management Process ···································································································································································································································· 8
3.2 Qualification and responsibility and authority of Personnel ······································································································································································· 9
4.0 Risk Analysis ··························································································································································································································································· 12
4.1 Description of Device ··········································································································································································································································· 12
4.2 Intended Use and Identification of Characteristics related to the Safety of the Medical Device ······························································································ 14
4.3 Identification of Hazards ····································································································································································································································· 26
4.4 Estimation of the Risk for Hazardous Situation ·························································································································································································· 26
5.0 Risk Evaluation ····················································································································································································································································· 27
6.0 Risk Control ····························································································································································································································································· 28
6.1 Risk Reduction ························································································································································································································································ 28
6.2 Risk Control Option Analysis ····························································································································································································································· 28
6.3 Implementation of Risk Control Measure ······································································································································································································· 28
6.4 Residual Risk Evaluation ······································································································································································································································ 29
6.5 Risk/benefit Analysis ············································································································································································································································· 31
6.6 Risks Arising from Risk Control Measures ···································································································································································································· 31
6.7 Completeness of Risk Control ··························································································································································································································· 31
7.0 Evaluation of Overall Residual Risk Acceptability ······················································································································································································· 32
8.0 Production and Post-Production Information ······························································································································································································· 33
9.0 Conclusion ······························································································································································································································································· 34
[Attachment 1] FMEA Report ···································································································································································································································· 34
1.0 Purpose
Risk management plan contains to the life cycle of our product of the planning, development, design, production, shipment, and
disposal. The purpose of the risk management is to estimate, evaluate, and control the risk to identify the hazard associated with
products according to EN ISO 14971:2012. In addition, risks related to our product shall be minimized through risk management
plan. Hence there is a purpose to prove that risks are minimized by preventing the loss of property and body of all persons
involved such as operators, users, etc.
2.0 Terms and definitions

2.1 Accompanying document : document accompanying a medical device and containing information for those
accountable for the installation, use and maintenance of the medical device, the
operator or the user, particularly regarding safety
2.2 Harm : physical injury or damage to the health of people, or damage to property or the environment
2.3 Hazard : potential source of harm
2.4 Hazardous situation : circumstance in which people, property, or the environment are exposed to one or more hazard(s)
2.5 Intended use & Intended purpose : use for which a product, process or service is intended according to the specifications,
instructions and information provided by the manufacturer
2.6 In vitro diagnostic medical device : medical device intended by the manufacturer for the examination of specimens derived from
the human body to provide information for diagnostic, monitoring or compatibility purposes
2.7 Life-cycle : all phases in the life of a medical device, from the initial conception to final decommissioning and disposal
2.8 manufacturer : natural or legal person with responsibility for the design, manufacture, packaging, or labelling of a medical device,
assembling a system, or adapting a medical device before it is placed on the market or put into service, regardless of whether these
operations are carried out by that person or on that person's behalf by a third party
2.9 Medical device : any instrument, apparatus, implement, machine, appliance, implant, in vitro reagent or calibrator, software,
material or other similar or related article, intended by the manufacturer to be used, alone or in combination, for human beings for
one or more of the specific purpose(s) of
- diagnosis, prevention, monitoring, treatment or alleviation of disease,
- diagnosis, monitoring, treatment, alleviation of or compensation for an injury,
- investigation, replacement, modification, or support of the anatomy or of a physiological process,
- supporting or sustaining life,
- control of conception,
- disinfection of medical devices,
- providing information for medical purposes by means of in vitro examination of
specimens derived from the human body, and which does not achieve its primary intended action in or on the human body by
pharmacological, immunological or metabolic means, but which may be assisted in its function by such means
- aids for disabled/handicapped people,
- devices for the treatment/diagnosis of diseases and injuries in animals,
- accessories for medical devices (see Note 3),
- disinfection substances,
- devices incorporating animal and human tissues which can meet the requirements of the above definition but are subject to
different controls.
2.10 Objective evidence : data supporting the existence or verity of something
2.11 Post-production : part of the life-cycle of the product after the design has been completed and the medical device has been
manufactured
2.12 Procedure : specified way to carry out an activity or a process
2.13 Process : set of interrelated or interacting activities which transforms inputs into outputs
2.14 Record : document stating results achieved or providing evidence of activities performed
2.15 Residual risk : risk remaining after risk control measures have been taken
2.16 Risk : combination of the probability of occurrence of harm and the severity of that harm
2.17 Risk analysis : systematic use of available information to identify hazards and to estimate the risk
2.18 Risk assessment : overall process comprising a risk analysis and a risk evaluation
2.19 Risk control : process in which decisions are made and measures implemented by which risks are reduced to, or maintained
within, specified levels
2.20 Risk estimation : process used to assign values to the probability of occurrence of harm and the severity of that harm
2.21 Risk evaluation : process of comparing the estimated risk against given risk criteria to determine the acceptability of the risk
2.22 Risk management : systematic application of management policies, procedures and practices to the tasks of analysing,
evaluating, controlling and monitoring risk
2.23 Risk management file : set of records and other documents that are produced by risk management
2.24 Safety : freedom from unacceptable risk

2.25 Severity : measure of the possible consequences of a hazard
2.26 Top management : person or group of people who direct(s) and control(s) a manufacturer at the highest level
2.27 Use error : act or omission of an act that results in a different medical device response than intended by the manufacturer or
expected by the user
2.28 Verification : confirmation, through the provision of objective evidence, that specified requirements have been fulfilled.
3.0 General requirements for risk management

3.1 Risk Management Process
3.2 Qualification and responsibility and authority of Personnel

(1) A separate organization is not specially made to implement risk management procedure. Every staff in charge of the works that
may have effect on product quality shall keep working on risk management by observing the documented quality management
system containing Risk Management Procedure(GNI-QP-701) and each product based quality plan.
(2) Qualifications and business scope of personnel participating in the overall risk management described in detail Risk Management
Plan(GNI-RMP-001).
(3) Performed personnel, the organization's identity, scope and performing date executed risk analysis show the following table.
Performing
Phase Scope Evidence Performer Review Approval
Date
① Identify and describe each step of the medical device and shelf-life to
which each element is applied
② Establish responsibility and authority at each stage
③ Requirements for review of risk management activities
④ Permissible risk levels including criteria of permissible risk as the Jung Hyun, Young Dug Soo,
Risk Plan ISO14971 Annex F 2017.08.01
manufacturer's policy base for determining permissible risk when potential Lee Kyun, Kim Kim
risk cannot be estimated
Potential hazards
⑤ Verification activities
⑥ Activities regarding relevant production and data collection and review
① Intended Use and Identification of Characteristics related to the Safety of ISO14971 Annex C
Risk the Medical Device ISO14971 Annex E Jung Hyun, Young Dug Soo,
2018.01.22
Analysis ② Identification of Hazards, Risk Estimation Relevant thesis & Lee Kyun, Kim Kim
③ Experiences Gotten from Similar Products data
Risk Sale experienced Jung Hyun, Young Dug Soo,

① Determine whether to take control measures against risk factors
data of similar 2018.01.26
Evaluation confirmed through risk analysis Lee Kyun, Kim Kim
products
Performing
Phase Scope Evidence Performer Review Approval
Date
① Risk reduction
② Risk control option analysis
③ Implementation of risk control measure(s) ISO14971
Jung Hyun, Young Dug Soo,
Risk Control ④ Residual risk evaluation Relevant thesis & 2018.01.30
⑤ Risk/benefit analysis data Lee Kyun, Kim Kim
⑥ Risks arising from risk control measures
⑦ Completeness of risk control
Evaluation of ① Determine whether to accept residual risk based on the standards defined
in the risk control plan Jung Hyun, Young Dug Soo,
overall
② For an overall residual risk that is judged acceptable, the manufacturer ISO14971 2018.02.02
residual risk Lee Kyun, Kim Kim
shall decide which information is necessary to include in the accompanying
acceptability documents in order to disclose the overall residual risk.
① The risk management plan has been appropriately implemented

② The overall residual risk is acceptable
Risk Jung Hyun, Dug Soo,
③ Appropriate methods are in place to obtain relevant production and
management ISO14971 2018.05.23 Sujin Shin
post-production information. Lee Kim
report ④ A series of courses including risk analysis, risk assessment, risk control
and evaluation of residual risk acceptability are recorded and documented.
Production ① Information obtained after manufacture and using this information to

A/S Diary or Scheduled Byeongsuk Young Dug Soo,
and re-evaluate risks
Customer
post-producti ② Production and the analysis of post-production information and organizing to perform Lee Kyun, Kim Kim
meetings Complaint Report
on information
(4) Qualifications of personnel participating in the overall risk management show the following table.
NO. Name Title Career Qualification
2+ years in
Jung Hyun, QUALITY
1 Quality Control / Risk Management Medical device’s
Lee CONTROL
company
Development/Quality Control 10+ years in
Young Kyun, QUALITY
2 bachelor's degree in New Materials Medical device’s
Kim MANAGER
Engineering company
5+ years in
SALES Oversea Sales / Customer
3 Grace Shin Medical device’s
MANAGER Complaint Handling
company
2 years in
Byeongsuk PRODUCTION
4 Production production of
Lee MANAGER
Medical device
20+ years in
Dug Soo,
5 CEO Approval Medical device’s
Kim
company
4.0 Risk Analysis

4.1 Description of Device
4.1.1 Intended Use of Device
Orthodontic Ceramic Bracket [VENUS Bracket, ROSE Bracket, ROSA Bracket] is an orthodontic bracket attached to teeth for
straightening irregular teeth.
4.1.2 Outline of Device

Orthodontic Ceramic Bracket [VENUS Bracket, ROSE Bracket, ROSA Bracket] is an orthodontic bracket attached to teeth to
recover aesthetics and function of malocclusion. Made with aluminum oxide, it is attached to teeth and straightens irregular
teeth with orthodontic wire installed through the wire’s elasticity.
4.1.3 External Appearance

(1) VENUS Bracket
(2) ROSE Bracket
(3) ROSA Bracket
※ Detailed description of the Orthodontic Ceramic Bracket [VENUS Bracket, ROSE Bracket, ROSA Bracket] is illustrated in the
Technical File (GNI-TF-001).
4.2 Intended Use and Identification of Characteristics related to the Safety of the Medical Device
4.2.1 EN ISO14971:2012, Annex C & IEC62366:2007, Annex E
A or
EN ISO14971:2012, Annex C & IEC62366:2007, Annex E Relationships with Products
N/A
Made with aluminum oxide, it is attached to teeth and
1. What is the intended use and how is the medical device to be used? A straightens irregular teeth with orthodontic wire installed
through the wire’s elasticity.
Factors that should be considered include:
① what is the medical device's role relative to
This product is a material to be attached to teeth for tooth
diagnosis, prevention, monitoring, treatment or alleviation of disease, A
correction.
compensation for injury or handicap or
replacement or modification of anatomy, or control of conception
② what are the indications for use (e.g. patient population)? A This product is a single-use.
③ does the medical device sustain or support life? N/A This product is not a life-support medical device.
④ is special intervention necessary in the case of failure of the medical
N/A No intervention is necessary.
device?
2. Is the medical device intended to be implanted?
Factors that should be considered include the location of implantation, the
characteristics of the patient population, age, weight, physical activity, the N/A It is a surgical instrument not implanted in human body.
effect of ageing on implant performance, the expected lifetime of the implant,
the reversibility of the implantation.
A or
N/A
3. Is the medical device intended to be in contact with the patient or
Human contact part (according to EN ISO10993-1 Annex A)
other persons?
1) Category : Surface Device
Factors that should be considered include the nature of the intended A
2) Contact : Mucosal Membrane
contact, i.e. surface contact, invasive contact, or implantation and, for
3) Contact duration : C [Permanent(〉30 d)
each, the period and frequency of contact.
This product consists of bio-compatible raw materials.
4. What materials or components are utilized in the medical device or are VENUS Bracket ROSE Bracket ROSA Bracket
A polycrystalline polycrystalline monocrystalline
used with, or are in contact with, the medical device? Body
alumina alumina alumina
Clip SUS 304 N/A N/A
Factors that should be considered include: Only materials which have been proven to be compatible with
A
① compatibility with relevant substances; human tissues are utilized for this product.
Only materials which have been proven to be compatible with

② compatibility with tissues or body fluids; A tissues or body fluids are utilized for this product.
Safety in the human body has been proven through biological

③ whether characteristics relevant to safety are known; A
safety assessment.
④ is the device manufactured utilizing materials of animal origin?

N/A This product is irrelevant to materials of animal origin.
NOTE See Annex I and also the ISO 22442 series of standards[19]
A or
N/A
5. Is energy delivered to or extracted from the patient?

Factors that should be considered include: N/A
① the type of energy transferred;
This product is not energy delivered to or extracted from the
patient.
② its control, quality, quantity, intensity and duration; N/A
③ whether energy levels are higher than those currently used for similar
N/A
devices.
6. Are substances delivered to or extracted from the patient?

① whether the substance is delivered or extracted;
This product is not substances delivered to or extracted from
the patient.
② whether it is a single substance or range of substances; N/A
③ the maximum and minimum transfer rates and control thereof. N/A
7. Are biological materials processed by the medical device for subsequent

re-use, transfusion or transplantation?
The device is not medical device for subsequent re-use,
Factors that should be considered include the type of process and N/A
transfusion or transplantation
substance(s) processed (e.g. autotransfusion, dialysis, blood component
or cell therapy processing).
A or
N/A
8. Is the medical device supplied sterile or intended to be sterilized by the
N/A -.This product is not supplied sterile.
user, or are other microbiological controls applicable?[E.2.1]
This product is intended for single use packaging and it is
① whether the medical device is intended for single use or re-use A
non-sterile.
packaging;
② shelf-life issues; N/A There is not shelf-life for this medical device.
③ limitation on the number of re-use cycles; N/A This product is not intended to be re-used.
④ method of product sterilization; N/A This product is not supplied sterile.
⑤ the impact of other sterilization methods not intended by the
N/A This product is not supplied sterile.
manufacturer.
9. Is the medical device intended to be routinely cleaned and disinfected
by the user?
Factors that should be considered include the types of cleaning or
disinfecting agents to be used and any limitations on the number of N/A This product is intended for single use only and so it is not
cleaning cycles. The design of the medical device can influence the intended to be routinely cleaned and disinfected.
effectiveness of routine cleaning and disinfection. In addition,
consideration should be given to the effect of cleaning and disinfecting
agents on the safety or performance of the device.
10. Is the medical device intended to modify the patient environment?
① temperature;
② humidity; N/A This product does not affect the patient environment.
③ atmospheric gas composition; N/A
④ pressure; N/A
⑤ light. N/A
A or
N/A
11. Are measurements taken?[E.2.2]
Factors that should be considered include the variables measured and N/A This product is not a medical device used for measuring.
the accuracy and the precision of the measurement results.
12. Is the medical device interpretative?

Factors that should be considered include whether conclusions are
presented by the medical device from input or acquired data, the N/A This product is not a medical device used for interpreting.
algorithms used, and confidence limits. Special attention should be given
to unintended applications of the data or algorithm.
13. Is the medical device intended for use in conjunction with other
medical devices, medicines or other medical technologies?[E.2.3] This medical device is intended for use in conjunction with
Factors that should be considered include identifying any other medical dental adhesives and an archwire, and a clip or a rubber
A
devices, medicines or other medical technologies that can be involved ring or a ligation wire is used to fix the archwire. In some
and the potential problems associated with such interactions, as well as cases, mini screws are used for orthodontic correction.
patient compliance with the therapy.
14. Are there unwanted outputs of energy or substances?[E.2.4]
Energy-related factors that should be considered include noise and
vibration, heat, radiation (including ionizing, non-ionizing, and
ultraviolet/visible/infrared radiation), contact temperatures, leakage
currents, and electric or magnetic fields. It is not a medical device susceptible to environmental
N/A
Substance-related factors that should be considered include substances influences.
used in manufacturing, cleaning or testing having unwanted physiological
effects if they remain in the product.
Other substance-related factors that should be considered include
discharge of chemicals, waste products, and body fluids.
A or
N/A
15. Is the medical device susceptible to environmental influences?[E.2.5]

Factors that should be considered include the operational, transport and
It is not a medical device susceptible to environmental
storage environments. These include light, temperature, humidity, N/A
influences.
vibrations, spillage, susceptibility to variations in power and cooling
supplies, and electromagnetic interference.
16. Does the medical device influence the environment?

It does not the medical device influence the environment.
This product has no influence on supply of electricity.
① the effects on power and cooling supplies;
② emission of toxic materials; N/A This is irrelevant to emission of toxic materials.
③ the generation of electromagnetic disturbance. N/A This is irrelevant to emission of Electromagnetic waves.
17. Are there essential consumables or accessories associated with the

medical device?[E.2.6] This medical device is intended for use in conjunction with
Factors that should be considered include specifications for such A dental adhesives and an archwire, and a rubber ring or a
consumables or accessories and any restrictions placed upon users in ligation wire is also used along with it.
their selection of these.
18. Is maintenance or calibration necessary?[E.2.7]
N/A
① whether maintenance or calibration are to be carried out by the Maintenance or calibration is not necessary for this medical
operator or user or by a specialist; device.
② are special substances or equipment necessary for proper
N/A
maintenance or calibration?
A or
N/A
19. Does the medical device contain software?
Factors that should be considered include whether software is intended
N/A This medical device does not contain software.
to be installed, verified, modified or exchanged by the operator or user
or by a specialist.
20. Does the medical device have a restricted shelf-life?[E.2.8]

Factors that should be considered include labelling or indicators and the N/A There is no shelf-life.
disposal of such medical devices when the expiration date is reached.
21. Are there any delayed or long-term use effects?[E.2.9]

Factors that should be considered include ergonomic and cumulative
This product is not medical device having delayed or
effects. Examples could include pumps for saline that corrode over time, N/A
long-term use effects.
mechanical fatigue, loosening of straps and attachments, vibration
effects, labels that wear or fall off, long term material degradation.
22. To what mechanical forces will the medical device be

subjected?[E.2.10]
Factors that should be considered include whether the forces to which A This product should be used only by a medical specialist.
the medical device will be subjected are under the control of the user or
controlled by interaction with other persons.
23. What determines the lifetime of the medical device?

A The lifetime of this product is semi-permanent.
Factors that should be considered include aging and battery depletion.
A or
N/A
24. Is the medical device intended for single use?[E.2.11]
Factors that should be considered include: does the medical device A This medical device is single use.
self-destruct after use? Is it obvious that the device has been used?
25. Is safe decommissioning or disposal of the medical device necessary?
Factors that should be considered include the waste products that are This product should be disposed of according to medical
A
generated during the disposal of the medical device itself. For example, waste disposal methods.
does it contain toxic or hazardous material, or is the material recyclable?
26. Does installation or use of the medical device require special training
or special skills?[E.2.12]
A This medical device is intended to be used by a dentist.
Factors that should be considered include the novelty of the medical
device and the likely skill and training of the person installing the device.
27. How will information for safe use be provided?[E.2.13]
① whether information will be provided directly to the end user by the The Instructions For Use is provided along with this medical
A
manufacturer or will it involve the participation of third parties such as device and this product is intended to be used by a dentist.
installers, care providers, health care professionals or pharmacists and
whether this will have implications for training;
② commissioning and handing over to the end user and whether it is
This product is not a medical device requiring handing over
likely/possible that installation can be carried out by people without the N/A
or installation.
necessary skills;
③ based on the expected life of the device, whether re-training or This product is not a medical device which requires training
N/A
re-certification of operators or service personnel would be required. of operators or service personnel.
28. Will new manufacturing processes need to be established or introduced?
This product is not a medical device need to be established
Factors that should be considered include new technology or a new N/A
or introduced new manufacturing process.
scale of production.
A or
N/A
29. Is successful application of the medical device critically dependent on Successful application of the medical device is not critically
N/A
human factors such as the user interface? dependent on humans factors such as the user interface.
29.1. Can the user interface design features contribute to use

error?[E.2.14]
Factors that should be considered are user interface design features that
can contribute to use error. Examples of interface design features
For this product, the user interface design features hardly
include: control and indicators, symbols used, ergonomic features, N/A
contribute to use error.
physical design and layout, hierarchy of operation, menus for software
driven devices, visibility of warnings, audibility of alarms, standardization
of colour coding. See IEC 60601-1-6[25] for additional guidance on
usability and IEC 60601-1-8[26] for guidance on alarms.
29.2. Is the medical device used in an environment where distractions can
cause use error?[E.2.15]
N/A
① the consequence of use error; This product should be used only in dental clinic
② whether the distractions are commonplace; N/A
③ whether the user can be disturbed by an infrequent distraction N/A

29.3. Does the medical device have connecting parts or
accessories?[E.2.16] This medical device is intended for use in conjunction with
Factors that should be considered include the possibility of wrong A dental adhesives and an archwire, and a rubber ring or a
connections, similarity to other products' connections, connection force, ligation wire is also used along with it.
feedback on connection integrity, and over- and under-tightening.
A or
N/A
29.4. Does the medical device have a control interface?[E.2.17]

Factors that should be considered include spacing, coding, grouping,
mapping, modes of feedback, blunders, slips, control differentiation, N/A The medical device does not have control interface.
visibility, direction of activation or change, whether the controls are
continuous or discrete, and the reversibility of settings or actions.
29.5. Does the medical device display information?[E.2.18]

Factors that should be considered include visibility in various
environments, orientation, the visual capabilities of the user, populations N/A The medical device does not display information.
and perspectives, clarity of the presented information, units, colour
coding, and the accessibility of critical information.
29.6. Is the medical device controlled by a menu?[E.2.19]

Factors that should be considered include complexity and number of
layers, awareness of state, location of settings, navigation method,
N/A The medical device is not controlled by a menu.
number of steps per action, sequence clarity and memorization problems,
and importance of control function relative to its accessibility and the
impact of deviating from specified operating procedures.
A or
N/A
29.7. Will the medical device be used by persons with special
needs?[E.2.20]
Factors that should be considered include the user, their mental and
physical abilities, skill and training, ergonomic aspects, the use
environment, installation requirements, and the patient's capability to
This product is not a medical device to be used by persons
control or influence the use of the medical device. Special attention N/A
who require nursing care.
should be paid to users with special needs, such as handicapped
persons, the elderly and children. Their special needs might include
assistance by another person to enable the use of a medical device. Is
the medical device intended to be used by individuals with various skill
levels and cultural backgrounds?
29.8. Can the user interface be used to initiate user actions?

Factors that should be considered include the possibility of initiating a
It is irrelevant the user interface be used to initiate user
deliberate action for the user to enter a controlled operation mode, which N/A
actions.
enlarges the risks for the patient and which creates awareness for the
user for this condition.
30. Does the medical device use an alarm system?

Factors that should be considered are the risk of false alarms, missing
alarms, disconnected alarm systems, unreliable remote alarm systems, N/A The medical device dose not use an alarm system.
and the medical staff's possibility of understanding how the alarm system
works. Guidance for alarm systems is given in IEC 60601-1-8[26].
A or
N/A
31. In what way(s) might the medical device be deliberately
misused?[E.2.21]
Factors that should be considered are incorrect use of connectors, N/A No possibility of deliberately misusing this product exits.
disabling safety features or alarms, neglect of manufacturer's
recommended maintenance.
32. Does the medical device hold data critical to patient care?
This product is not the medical device having data critical to
Factors that should be considered include the consequence of the data N/A
patient care.
being modified or corrupted.
33. Is the medical device intended to be mobile or portable?[E.2.22]

Factors that should be considered are the necessary grips, handles, N/A The medical device is not intended to be mobile or portable.
wheels, brakes, mechanical stability and durability.
34 Does the use of the medical device depend on essential performance?

Factors that should be considered are, for example, the characteristics of
the output of life-supporting devices or the operation of an alarm. N/A This product is not a life-supporting device.
See IEC 60601-1[23] for a discussion of essential performance of
medical electrical equipment and medical electrical systems.
4.3 Identification of Hazards

see the attached section 4.3 of FMEA Report for identification of hazards based on EN ISO 14971:2012.
[Attachment] : FMEA Report
4.4 Estimation of the Risk for Hazardous Situation

see the attached section 4.4 of FMEA Report for identification of hazards based on EN ISO 14971:2012.
5.0 Risk Evaluation

(1) see the attached section 5 of FMEA Report for the risk evaluation.
(2) As a result of risk evaluation, a total of 30 risks are identified and 22 risks require control measures. However, our company
took a control measure against all 30 risks to minimize risks.
Severity
1 Negligible 2 Marginal 3 Serious
Probability
4 Occasional
3 Remote 2 6 14
2 Improbable 7 2
1 Incredible
Grade Result Risk needed control Risk unneeded control

measures measures
Green Zone : Acceptable 9
Red Zone : Non-Acceptable 22

22 9
Total 31
6.0 Risk Control

6.1 Risk Reduction
(1) The quality manager should conduct actions for risk control as demonstrated in risk control (from alternative analyses to
completion of risk control) when risks are required to be reduced.
6.2 Risk Control Option Analysis

(1) see the attached section 6.2 of FMEA Report for the evidences of conducting the risk control option analysis
6.3 Implementation of Risk Control Measure

(1) see the attached section 6.3 of FMEA Report for the evidences of conducting the risk control measure
6.4 Residual Risk Evaluation

(1) see the attached section 6.4 of FMEA Report for the residual risk evaluation
(2) Control measures to identified hazards(harms) have been carried out; each remaining harm has been proved to be acceptable
when assessing them after control measures to harms.
[Before Risk Control]
Severity
Probability
4 Occasional
3 Remote 2 6 14
2 Improbable 7 2
1 Incredible
[After Risk Control]

Severity
Probability
4 Occasional
3 Remote
2 Improbable
1 Incredible 2 13 16
(3) The residual risk for Orthodontic Ceramic Bracket [VENUS Bracket, ROSE Bracket, ROSA Bracket] was reduced to the acceptable
level after risk control measures were implemented.
6.5 Risk/benefit Analysis

(1) Risks are considerably reduced or removed through residual risk evaluation. Risks are all evaluated as acceptable.
(2) Regardless of risks’ acceptability, however, EN ISO 14971:2012 requires Risk/Benefit analysis on all individual and overall risks.
(3) see the attached section 6.5 of FMEA Report for risk/Benefit analysis on all of identified risks
6.6 Risks Arising from Risk Control Measures

(1) There are currently no risks incurred from actions for risk control on Orthodontic Ceramic Bracket [VENUS Bracket, ROSE
Bracket, ROSA Bracket] through risk management procedure.
6.7 Completeness of Risk Control

(1) It is proved that there are no more risks on the company's Orthodontic Ceramic Bracket [VENUS Bracket, ROSE Bracket, ROSA
Bracket] through risk management procedure.
7.0 Evaluation of Overall Residual Risk Acceptability

(1) All hazardous factors identified after risk control have entered into the Green zone; it can be said that risk control activity has
been performed successfully. Thus, additional risk control activity will not be necessary.
(2) According to the risk/benefit analysis, each residual risk of the Orthodontic Ceramic Bracket [VENUS Bracket, ROSE Bracket,
ROSA Bracket] is no higher that the benefits of the medical device; all has been proved to be acceptable.
(3) Risks are reduced after taking proper risk control measures but there are still additional residual risks incurred by each residual
risk and combination or interference of each residual risk. Nevertheless, benefits from using the product exceed the additional
residual risks incurred by combination or interference of each residual risk. Therefore, it is confirmed that benefits from using
Orthodontic Ceramic Bracket [VENUS Bracket, ROSE Bracket, ROSA Bracket] exceed overall residual risks.
(4) According to the literatures on clinical evaluation report, it is also shown that the treatment with our product and the treatment
with other products are similarly safe and effective.
(5) And clinical literatures in clinical evaluation show that procedures using similar products to our product are safe and effective.
In this respect, it can be said that the benefits from using our product outweigh the risks.
8.0 Production and Post-Production Information

(1) Production and post-production information of Orthodontic Ceramic Bracket [VENUS Bracket, ROSE Bracket, ROSA Bracket]was
checked in accordance with Risk Management Plan (GNI-RMP-001).
(2) There is no product sales record of Orthodontic Ceramic Bracket [VENUS Bracket, ROSE Bracket, ROSA Bracket]. Production
and post-production information was not reflected.
9.0 Conclusion
(1) As long as users use our product in accordance with Instruction for use in the normal situation, there will be low risk to users.
However, there are potential risks in the aspects of Energy Hazards, Biological and Chemical hazards, Operational Hazards and
Information Hazards, Etc. of the medical device to the use of the medical device.
(2) The risk management Report comprises the analyses and actions to potential risks of the Orthodontic Ceramic Bracket [VENUS
Bracket, ROSE Bracket, ROSA Bracket]produced by the GNI Co., Ltd. in accordance with EN ISO14971(2012) standard.
(3) We have a risk management and taken an action against risks. The evaluation mark of this analysis and action-taking is in the
range of acceptable zone. It is verified that this risk level is safe for use of the relevant product.
[Attachment 1] FMEA Report

01 Risk Management Report

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Risk Management Report

Controlled No. □ Controlled ( ) □ Uncontrolled

Applied Standard : EN ISO14971(2012)

Department/Title Name Date Signature

Sales & Quality Team /

Approval President Dug Soo, Kim 2018.05.23

Rev. No. Revision Date Reasons of Revision

0 2017.08.22 Newly established

1 2018.02.07 Revised due to corrective action of CE Audit

2 2018.05.23 Revised due to corrective action of CE Audit

2.0 Terms and definitions

2.3 Hazard : potential source of harm

2.10 Objective evidence : data supporting the existence or verity of something

2.12 Procedure : specified way to carry out an activity or a process

2.24 Safety : freedom from unacceptable risk

2.25 Severity : measure of the possible consequences of a hazard

3.0 General requirements for risk management

3.2 Qualification and responsibility and authority of Personnel

Risk Sale experienced Jung Hyun, Young Dug Soo,

① The risk management plan has been appropriately implemented

Production ① Information obtained after manufacture and using this information to

NO. Name Title Career Qualification

4.0 Risk Analysis

4.1.2 Outline of Device

4.1.3 External Appearance

(2) ROSE Bracket

(3) ROSA Bracket

This product consists of bio-compatible raw materials.

Only materials which have been proven to be compatible with

Safety in the human body has been proven through biological

④ is the device manufactured utilizing materials of animal origin?

5. Is energy delivered to or extracted from the patient?

6. Are substances delivered to or extracted from the patient?

7. Are biological materials processed by the medical device for subsequent

12. Is the medical device interpretative?

15. Is the medical device susceptible to environmental influences?[E.2.5]

16. Does the medical device influence the environment?

② emission of toxic materials; N/A This is irrelevant to emission of toxic materials.

17. Are there essential consumables or accessories associated with the

20. Does the medical device have a restricted shelf-life?[E.2.8]

21. Are there any delayed or long-term use effects?[E.2.9]

22. To what mechanical forces will the medical device be

23. What determines the lifetime of the medical device?

29.1. Can the user interface design features contribute to use

③ whether the user can be disturbed by an infrequent distraction N/A

29.4. Does the medical device have a control interface?[E.2.17]

29.5. Does the medical device display information?[E.2.18]

29.6. Is the medical device controlled by a menu?[E.2.19]

29.8. Can the user interface be used to initiate user actions?

30. Does the medical device use an alarm system?

33. Is the medical device intended to be mobile or portable?[E.2.22]

34 Does the use of the medical device depend on essential performance?

4.3 Identification of Hazards

4.4 Estimation of the Risk for Hazardous Situation

5.0 Risk Evaluation

Grade Result Risk needed control Risk unneeded control

Red Zone : Non-Acceptable 22

6.0 Risk Control

6.2 Risk Control Option Analysis

6.3 Implementation of Risk Control Measure

6.4 Residual Risk Evaluation

[After Risk Control]

6.5 Risk/benefit Analysis