Risk Management Plan
Product Name: XXX
Model Name: XXX
MANUFACTURE NAME HERE
Issue review Approval
Name /
Signature
Date YYYY.MM.DD YYYY.MM.DD YYYY.MM.DD
File Number.: XXX (Rev.0)
Date: YYYY.MM.DD
Revision history
Title Risk management plan for XXX
File Number XXX (Rev.0) Revision Number 0
No. Issued Revision contents Date Signature
Initial YYYY.MM.DD
1 Initial release for the model XXX
Release
2
10
11
12
13
14
15
16
17
18
19
20
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Table of contents
1 General
2 Scope of the plan
3 Assignment of responsibilities and authorities
4 Requirements for review of risk management activities
5 Criteria for risk acceptability including criteria for accepting risks when the probability
of occurrence of harm cannot be estimated
6 Verification activities
7 Method or methods of obtaining relevant post-production information
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1 General
1.1 Introduction
This risk management plan was made to analyze the risk factors as to xxx designed and
manufactured by xxx, and applied to the whole life cycle, including phases from initial development
to final disposal.
Our purpose is to reduce the risk, below the required level, of product-related aspects including
producxt itself, its users, patients etc. by analyzing and controlling the risks of harm that could occur
during the whole period of life cyclce, through this risk management plan.
Primary implementation methods and procedures stipulated in this risk management plan was
conducted in accordance with EN ISO 14971:2012 and IEC 60601-1:2005 + A1:2012. (please
adjust these standards)
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1.2 Normative references
1.2.1 EN ISO 14971:2012
Medical devices Application of risk management to medical devices
1.2.2 IEC 60601-1:2005 + A1:2012
Medical electrical equipment - Part 1: General requirements for basic safety and essential
performance
1.2.3 IEC 60601-1-2:2007
Medical electrical equipment - Part 1-2: General requirements for safety and essential
performance - Collateral standard: Electromagnetic compatibility - Requirements and tests
1.2.5 IEC 60601-1-6:2010
Medical electrical equipment - Part 1-6: General requirements for safety and essential
performance - Collateral standard: Usability
1.2.6 IEC 62366:2008
Medical devices - Application of usability engineering to medical devices
1.2.7 IEC 62304:2006
Medical device software - Software life cycle processes
1.2.8 ISO 15223-1:2012
Medical devices - Symbols to be used with medical device labels, labelling and information to
be supplied - Part 1: General requirements
1.2.9 EN 1041:2008
Information supplied by the manufacturer with medical devices
1.2.10 IEC 60417:2002
Graphical symbols for use of on equipment
1.2.11 ISO 7010:2011
Graphical symbols - Safety colors and safety signs - Registered safety signs
1.2.12 ISO 10993
Biological Evaluation of Medical Devices Package
1.2.13 EN ISO 13485:2012
Medical device - Quality management system -Requirements for regulatory purposes
1.2.14 IECEE OD-2044 (ed.2.2)
Operational & Ruling Documents - Evaluation of Risk Management in medical electrical
equipment
1.2.15 Council Directive 93/42/EEC of 14 June 1993 as amended by Directive 2007/47/EC
concerning medical devices
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1.3 Terms and definitions
1.3.1 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
1.3.2 Harm
physical injury or damage to the health of people, or damage to property or the environment
1.3.3 Hazard
potential source of harm
1.3.4 Hazardous situation
circumstance in which people, property, or the environment are exposed to one or more
hazard(s)
1.3.5 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
1.3.6 In vitro diagnostic medical device
IVD 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
1.3.7 Life-cycle
all phases in the life of a medical device, from the initial conception to final decommissioning
and disposal
1.3.8 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 third party
1.3.9 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
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1.3.10 Objective evidence
data supporting the existence or verity of something
1.3.11 Post-production
part of the life-cycle of the product after the design has been completed and the medical
device has been manufactured
1.3.12 Procedure
specified way to carry out an activity or a process
1.3.13 Process
set of interrelated or interacting activities which transforms inputs into outputs
1.3.14 Record
document stating results achieved or providing evidence of activities performed
1.3.15 Residual risk
risk remaining after risk control measures have been taken
1.3.16 Risk
combination of the probability of occurrence of harm and the severity of the harm
1.3.17 Risk analysis
systematic use of available information to identify hazards and to estimate the risk
1.3.18 Risk assessment
overall process comprising a risk analysis and a risk evaluation
1.3.19 Risk control
process in which decisions are made and measures implemented by which risks are reduced
to, or maintained within, specified levels
1.3.20 Risk estimation
process used to assign values to the probability of occurrence of harm and the severity of that
harm
1.3.21 Risk evaluation
process of comparing the estimated risk against given risk criteria to determine the
acceptability of the risk
1.3.22 Risk management
systematic application of management policies, procedures and practices to the tasks of
analysing, evaluating, controlling and monitoring risk
1.3.23 Risk management file
set of records and other documents that are produced by risk management
1.3.24 Safety
freedom from unacceptable risk
1.3.25 Severity
measure of the possible consequences of a hazard
1.3.26 Top management
person or group of people who direct(s) and control(s) a manufacturer at the highest level
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1.3.27 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
1.3.28 Verification
confirmation, through the provision of objective evidence, that specified requirements have
been fulfilled
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1.4 Management responsibilities
1.4.1 Provision of adequate resources
See clause 3.1 of this risk management plan
1.4.2 Assignment of qualified personnel for risk management
See clause 3.2 of this risk management plan
1.4.3 Policy for determining criteria for risk acceptability
See clause 5 of this risk management plan
1.4.3 Continuing effectiveness of the risk management process
See clause 4 of this risk management plan, and quality management system
1.5 Qualification of personnel
The personnel performing risk management tasks to have the appropriate knowledge and
experience for the tasks assigned to them.
See clause 3.3 of this risk management plan
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2 Scope of the plan
This risk management plan is throughout the life-cycle an ongoing process for identifying
hazards associated with the XXX, estimating and evaluating the associated risks, controlling these
risks, and monitoring the effectiveness of the controls.
2.1 Product description
2.1.1 Introduction
This product is a(n) (please explain the product (surgical laser, ultrasound, microneedle, etc))
2.1.2 Product classification
- Medical device protection against electric shock: xxx
- Applied part protection against electric shock: Type xxx
- Degree of protection against ingress of water or particulate matter:
Unit: XXX
Probe: XXX
- Method of sterilization: XXX
- Suitability for use in an oxygen rich environment:
Medical device (intended/not intended) to be used in an oxygen rich environment
- Suitability to use medical device in the presence of a flammable anaesthetic mixture with air
or with oxygen or nitrous oxide:
Medical device (suitable/not suitable) for use in the presence of a flammable anaesthetic
mixture with air or with oxygen or nitrous oxide.
- Mode of operation: XXX
2.1.3 Environmental specifications
Operating
Ambient temperature range XXX °C
Relative humidity XXX%
Atmospheric pressure XXXhPa
Storage & Transportation
Ambient temperature range XXX°C
Relative humidity XXX %
Atmospheric pressure XXX hPa
2.1.4 Expected service life
life time: XXX hour (X years)
2.1.5 Other information
See User manual
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2.2 Identification and description of each life-cycle phases of a medical equipment
2.2.1 Overview of risk management activities
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2.2.2 The life-cycle phases for which each element of the plan
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2.2.2.1 Design Planning
Risk factors are analyzed in the design and development phase¸and each identified risk is
estimated by experiment in both conditions of normal and malfunction.
The results from the determination of whether the risk was reduced after risk assessment are
used as part of design input.
In the design, development and planning phases, all the implementation and examinations
are conducted by director of research, quality control manager, and technical experts.
2.2.2.2 Design & Development
The design and development include use, functional and performance-based safety, and
regulatory requirements.
The preliminary list of foreseeable risk factors are derived from checking out the relevant
standards, monitoring data services, and product test reports. Risk factors should be provided
to the design and development phase as a means of risk management.
2.2.2.3 Design Verification
Objective data should be prepared to show the following: the final results meeting the
acceptable criteria, adoption of risk management measures for identified risks, and verification
of efficiency of risk management measures.
2.2.2.4 Design Validation
Whether not only medical devices meet user’s needs or intended use, but also total residual
risks fall within acceptable criteria should be verified. In order to enhance the reliability, test
results from a certified testing institute and opinion of sales or production department should
be reflected.
2.2.2.5 Production
Equipments for production, measurement and monitoring should establish suitability of
equipment, cleaning, maintenance, correction cycle etc. by making reference to processor-
related risks.
2.2.2.6 Packing & Transport
Equipments finished in production phase are delivered to customers after the phases of
packaging and delivery, which should be documented under the control of risk management.
Packaging sequence and delivery method are very significant and working environment and
employees are under the control of risk management.
2.2.2.7 Post-Production
Once post-production information on medical and scientific technology development is
collected, monitoring is performed to apply eliminating measures of harm factors that were not
resolved by previous technology to medical devices. And elimination and reduction measures
are implemented along with identification of same harm factors upon gathering information on
risky situations that occurred or could have occurred in same or similar type of products by
other companies.
2.2.2.8 Monitoring
Monitor whether new risk factors exist by gathering post-production information. If new risk
factors are identified, perform risk management activity by going back to design input phase.
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3 Assignment of responsibilities and authorities
3.1 CEO
- Providing for risk management policy and goals
- Approval of risk management report and presiding over RM meeting
- Providing for human and financial resource
3.2 Director of Research
- Identification of risk factors, evaluation, assessment and establishing the effectiveness of
risk management
- Ensuring the availability of risk manager personnel
- The approval of risk management plan and report
3.3 Quality Representative
- Presiding over risk management meeting and reporting to CEO with meeting contents
- Reviewing risk management plan and report
- Confirmation of corrective action related with risk management
- Granting qualification of risk manager
3.4 Risk Manager (R&D Team Leader)
- Conducting action of risk analysis
- Conducting countermeasure of risk harm and reviewing it
- Conducting corrective action related with risk and reporting about it
- Writing of risk management plan & report and reporting about it
3.5 Product Team
- Establishing measures of risk management control and conducting process validation
- Offering to information about each step of risk management analysis, estimation and
management etc.
3.6 Sales Team
- Offering to the relevant divisions after gathering information related with risk harm
- Understanding the trends of similar firms
- Collecting of information (thesis and materials) related with production
- Removing of potential risk harm through managing subcontractors
3.7 Qualification
- Persons performing risk management tasks should be the knowledge and experience
appropriate for the products.
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3.8 Assignment of Personnel
Step Risk management activities Responsible Dept.
- Establishment of risk analysis procedures Quality
Management plan - Set-up of acceptable risk level and responsibilities & Representative /
authorities R&D Team
- Identification of characteristics
Risk analysis - Identification of hazards R&D Team
- Risk estimation
Risk evaluation - Risk evaluation R&D Team
- Risk control measures
- Implementation of measures and record verification
Risk control R&D Team
- Acceptability of residual risk
- Risk/benefit analysis
Overall residual risk
- Evaluation of overall residual risk R&D Team
evaluation
Quality
Risk management report - Making a risk management report and review Representative /
R&D Team
- Post-production information collection Quality
Production and post-
- Making a risk management report by reflecting post- Representative / CS
production information
production information Team
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4 Requirements for review of risk management activities
Stage Review Requirements
- Usage and choice of parts, materials and process
- Usage and choice of standards
- Usage and choice of allowable error
Design and development - Anticipated performance and analysis of reliability and safety
input - Evaluation of new technology, parts, materials and process
- Safety requirements(MDD Annex 1, standards of product, relevant official
notifications or regulations etc.)
- Risk Analysis
- It should be verified to meet the input requirements for design and development,
or should be expressed and documented to ensure effectiveness.
- It should include or quote measurable judgment criteria, such as allowable error,
Design and development Max, Min etc.
output - It should fugure out such user’s safety related items as safety device, warning
measures, caution sign etc.
- It should figure out product safety – operation, storage, treatment, maintenance,
disposal etc. – and design characteristics significant for proper functioning.
- Criteria for design and development review
- List of documentations reviewed
Design and development - Proof of design and development meeting requirements
review - Determination of whether to proceed to next phase
- Records of corrected contents
- Reasons of corrections and suggestions
- Product design standards to be verified
- Planning purpose
- Procedures and specifications to be implemented
- Understsanding of models to use for the proof of design requirements
- Explanations of verification activities
Design and development
- Explanations on facilities, equipments, and test equipments to use for verification
verification
activities
- Time scale
- Explanations on on-site inspection
- Explanations on doer of verification activities
- Explanations on procedural manuals, standards, specifications, and records
- Relevant documentations and data review
Design and development
- Collection and analysis of records of similar products use
validation
- Confirmation of product effectiveness by questionaire survey after field test.
- Establishment of suitability of equipment, cleaning, maintenance, correction cycle
- Information on unsuitability rate, reworking rate, disposal rate, passing rate, and
Production sources of quality data.
- Working environment and employees’ effect, as a means of managing risk
occurrence, on relevant products
- Effects caused by careless handling
Packing and shipping - Improper packaging and marking
- Risks that could happen at the time of improper transport, storage and delivery.
- Management of production and processor
Post-production - Correction and preventive measures
- Service and feedback data
- Information on competing manufacturer’s devices
- Information on similar medical devices newly released in the market
Monitoring - Publicized information (recall, medical device report, reports on safety against
side effect)
- Science-related literature
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5 Criteria for risk acceptability, based on manufacturer's
policy for determining acceptable risk, including criteria for
accepting risks when probability of occurrence of harm cannot
be estimated
Allowable criteria for risks were established in accordance with Annex D of EN ISO 14971:2012.
5.1 Severity of harm
Score Severity Possible description
5 Catastrophic Results in patient death
4 Critical Results in permanent impairment or life-threatening injury
Result in injury or impairment requiring professional medical
3 Serious
intervention
Results in temporary injury or impairment not requiring
2 Minor
professional medical intervention
1 Negligible Inconvenience or temporary discomfort
5.2 Probability of occurrence
Score Probability Definition
5 Frequent Occurrence probability is whenever device works
4 Probable Occurrence probability is once a day
3 Occasional Occurrence probability is once a month
2 Remote Occurrence probability is once a year
1 Improbable Occurrence probability is once for the device lifetime
5.3 Classification chart for the acceptance of risks
Sev. Negligible (1) Minor (2) Serious (3) Critical (4) Catastrophic (5)
Pro.
Frequent (5) 5 10 15 20 25
Probable (4) 4 8 12 16 20
Occasional (3) 3 6 9 12 15
Remote (2) 2 4 6 8 10
Improbable (1) 1 2 3 4 5
- Risk Level: Severity x Probability -
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5.4 Legend of Classification chart
- Green Zone (Risk level: 1 to 5): Acceptable zone
It is set as a broadly acceptable risk zone, in which risks in this zone do not need risk control.
- Red Zone (Risk level: 6 to 25): Unacceptable zone
It is an intolerable zone, in which cease of product development is needed, and should be reduced to
acceptable zone as low as possible through design change for risk reduction.
If residual risk still exits in an intolerable zone even after the elimination or reduction of risks, product
design should be stopped.
5.5 Manufacturer policy for determining acceptable risk of IEC 60601 series
The requirements of IEC 60601-1 standard are applied in the following way when evaluating risk;
1) Where IEC 60601-1 standard or its collateral or particular standards specify requirements
addressing particular hazards or hazardous situations, together with specific acceptance criteria:
Compliance with these requirements is presumed to establish that the residual risks have been
reduced to acceptable levels unless there is objective evidence to the contrary.
2) Where IEC 60601-1 standard or its collateral or particular standards specify requirements
addressing particular hazards or hazardous situations but do not provide specific acceptance criteria:
Compliance with acceptance criteria defined in the risk management plan.
- Criteria for risk acceptability:
a) Emissions, deformation of enclosure or exceeding maximum temperature
The following hazardous situations shall not occur:
- emission of flames, molten metal, poisonous or ignitable substance in hazardous
quantities;
- deformation of enclosures to such an extent that compliance with 15.3.1 of IEC
60601-1 standard is impaired;
- temperatures of applied parts exceeding the allowed values identified in Table 24
when measured as described in 11.1.3 of IEC 60601-1 standard;
- temperatures of Me equipment parts that are not applied parts but are likely to be touched,
exceeding the allowable values in Table 23 when measured and adjusted as described in
11.1.3 of IEC 60601-1 standard;
b) Exceeding leakage current or voltage limits
The following hazardous situations shall not occur:
- exceeding the limits for leakage current in single fault condition as indicated in 8.7.3 of IEC
60601-1 standard;
- exceeding the voltage limits for the accessible parts including applied parts indicated in 8.4.2
of IEC 60601-1 standard;
3) Where this standard or its collateral or particular standards identify particular hazards or
hazardous situations that have to be investigated without providing specific technical requirements:
- Determine whether such hazards or hazardous situations exist for the particular ME equipment or
ME system, and
- where such hazards or hazardous situations exist for the particular ME equipment or ME system,
the manufacturer shall evaluate and (if necessary) control these risks following the risk management
process specified in 4.2.2 of IEC 60601-1 standard.
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5.6 Hazards not identified in the IEC 60601-series
For hazards or hazardous situations that are identified for the particular ME equipment or ME system
but are not specifically addressed in this standard or its collateral or particular standards, the
manufacturer shall address those hazards in the risk management process as specified in 4.2.2 of
IEC 60601-1 standard.
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6 Verification activities
6.1 Classification by verification activity
Classification Phase description Reference Result Responsible
EN ISO 14971:2012
Risk Technical document Risk Quality
Establishment phases of the risk
management Customer requirements Management Representative
management plan
plan Risk management Plan / R&D Team
guideline (OD 2044)
Identification of intended use / EN ISO 14971:2012
Risk
intended purpose Expert(s) opinion
Risk analysis Management R&D Team
Identification and foreseeable of Risk management
Report
hazards guideline (OD 2044)
EN 60601-1:2013
EN ISO 14971: 2012 Risk
Risk
Evaluation of risk acceptability Expert(s) opinion Management R&D Team
evaluation
Risk management Plan
guideline (OD 2044)
EN 60601-1:2013
Risk reduction
EN ISO 14971: 2012 Risk
Risk control option analysis
Risk control Expert(s) opinion Management R&D Team
Implementation of risk control
Risk management Report
measure(s)
guideline (OD 2044)
EN 60601-1:2013
Residual risk evaluation
EN ISO 14971: 2012 Risk
Residual risk Risk/benefit analysis
EN ISO 13485: 2012 Management R&D Team
evaluation Decision of residual risk
Risk management Plan
acceptability
guideline (OD 2044)
EN 60601-1:2013
After all risk control measures
Risk EN ISO 14971: 2012 Risk Quality
have been implemented and
management Expert(s) opinion Management Representative
verified, the overall residual risk
report Risk management Report / R&D Team
is decide if acceptable
guideline (OD 2044)
Production EN ISO 14971: 2012
Post production information Risk Quality
and post- Customer surveys
Review of the risk management Management Representative
production Risk management
information Report / CS Team
information guideline (OD 2044)
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6.2 Implementation of risk management process by phase of verification activity
6.2.1 Identification of characteristics related to the safety of medical devices.
It is a phase to identify the qualitative and quantitative safety-related characteristics, and reflects
those characteristics to risk management plan by asking questions to identify the risks.
6.2.2 Identification of hazards
Identify perceived hazards based on the list on Annex E or anticipate predictable hazards by utilizing
the inductive risk analysis such as FMEA(Failure Mode and Effect Analysis) described in the Annex
G.
6.2.3 Risk estimation
Estimate the risk level of harm factors identified, in normal and fault conditions, based on the
available information and data. Record the estimation result in the risk management file.
6.2.4 Risk evaluation
It is a phase to evaluate the acceptability of risks and to determine risk factors identified by the use of
criteria specified in the risk management plan.
6.2.5 Risk control
It determines whether risks are reduced by risk control activities and decides proper measures and
means of risk control.
6.2.6 Implementation of risk control measures
Risk control measures specified in section 8.2.5 are performed, and the results of risk control
measures are recorded and reflected.
6.2.7 Residual risk evaluation
It is a phase to evaluate residual risk and determine the need of risk reduction as to each hazards
identified in step 4 by using Annex D, Section 3. If no need, proceed to broadly acceptable zone.
6.2.8 Risk/benefit analysis
It is a phase to evaluate medical usability, and the residual risk remaining after implementing risk
management measures is evaluated and documented in accordance with risk management plan.
6.2.9 Risk arising from risk control measures
It is a phase to identify new hazards. Risk control measures could cause new and entirely different
hazards to occur, so it is necessary to identify new hazards and review risk control measures.
6.2.10 Completion of risk control
.
This phase is to guarantee, by the results of risk analysis and confirmation of each department head,
that risk was evaluated in terms of all identified hazard, and such results should be documented in
risk management file.
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6.2.11 Evaluation of overall residual risk acceptability
This phase is to evaluate overall residual risk, where quality controller collects and reviews data on
benefit vs. risk, in regard to both whether all identified risks - from evaluation of risk management
plan after risk management measures were implanted and verified - were evaluated and whether the
residual risk is in broadly acceptable zone. And then the quality controller documents in risk
management file after determining whether to proceed with risk management report , or whether the
risk is not acceptable.
6.2.12 Risk management report
Risk management report is made by not only identifying all hazards that are already known or
foreseeable during risk analysis, but also providing grounds and sources for identification of hazards
by risk as well as objective and scientific grounds.
6.2.13 Post-production information acquisition
It is a phase of post-production information acquisition, in which management department head
obtains and review information on medical devices or similar ones, and then conveys the resulting
information to R&D department head for suitability evaluation.
If residual risk or residual risk’s acceptability changes, its impact on risk management measures that
were implemented before, and the results should be documented and maintained in the risk
management file.
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7 Method or methods of obtaining relevant post-production
information
7.1 Post-production information acquisition
7.1.1 It should be implemented according to the procedures of established quality management
system, and the information should be collected from various sources, including after-sales service
log, customer complaints, side effect report etc.
7.1.2 Post-production information should be obtained through preventative correction measures,
customer satisfaction survey etc. by sales department staffs. Such gathered information is utilized for
product improvement and risk reduction and , if necessary, should be reflected in risk management
report.
7.1.3 Various relevant standards should be reflected based on the reference to modified or updated
data.
- European standards set forth by European Commission:
http://ec.europa.eu/enterprise/policies/european-standards/harmonised-standards/medical-devices/
7.2 Customer satisfaction and analysis of demands
7.2.1 Personnel (in sales department) in charge of marketing and sales should examine and
document the responses from customer complaints and user’s feedback in accordance with
procedural manual for handling customer dissatisfaction.
7.2.2 Customer complaints should be received and documented in accordance with procedural
manual for handling customer dissatisfaction.
7.3 Inspection and internal audit
7.3.1 QM team leader should perform inspection and internal audit annually in accordance with
internal audit procedural manual, and then reflect the results from internal audit to risk management
by monitoring newly identified risk factors.
7.3.2 QM team leader should perform inspection in accordance with procedural manuals for
inspection and test management; monitor risk factors identified from test results; and apply them to
risk management.
7.4 Market report on similar medical devices and recall monitoring
7.4.1 Team leader in charge of certification should search for and examine market information on
similar medical devices by visiting the following websites on a regular basis, to order to reflect them
in products as well as risk management.
- KFDA: http://www.mfds.go.kr/index.jsp
- MHRA: http://www.mhra.gov.uk/
- FDA: http://www.fda.gov/MedicalDevices/default.htm
7.4.2 QM team leader should reflect such safety-related issues as side effect etc. to products after
identifying whether those issues need risk management.
Reference document
- Procedural manual for design tasks
- Procedural manual for risk management
- Procedural manual for handling customer dissatisfaction
- Procedural manual for managing non-conforming products
- Procedural manual for corrective or preventative measures
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