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  • Quality Manual
  • Procedures
    • GP-001 Control of documents
    • GP-002 Quality planning
    • GP-003 Audits
    • GP-004 Vigilance system
    • GP-005 Human Resources and Training
    • GP-006 Non-conformity, Corrective and Preventive actions
    • GP-007 Post-market surveillance
    • GP-008 Product requirements
    • GP-009 Sales
    • GP-010 Purchases and suppliers evaluation
    • GP-011 Provision of service
    • GP-012 Design, Redesign and Development
    • GP-013 Risk management
      • Templates
        • T-013-001 Risk management plan
        • T-013-002 Risk management record_YYYY_nnn
        • T-013-003 Risk management report
    • GP-014 Feedback and complaints
    • GP-015 Clinical evaluation
    • GP-016 Traceability and identification
    • GP-017 Technical assistance service
    • GP-018 Infrastructure and facilities
    • GP-019 Software validation plan
    • GP-020 QMS Data analysis
    • GP-021 Communications
    • GP-022 Document translation
    • GP-023 Change control management
    • GP-024 Cybersecurity
    • GP-025 Corporate Governance
    • GP-050 Data Protection
    • GP-051 Security violations
    • GP-052 Data Privacy Impact Assessment (DPIA)
    • GP-100 Business Continuity (BCP) and Disaster Recovery plans (DRP)
    • GP-101 Information security
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  • Procedures
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  • GP-013 Risk management
  • Templates
  • T-013-001 Risk management plan

T-013-001 Risk management plan

Scope​

This risk management plan describes the different risk management activities carried out throughout the entire product life cycle, the responsibilities and authorities of those involved, the criteria for risk acceptability, the activities for the verification of risk control measures, and the production and post-production information to be collected and reviewed for the medical device Legit.Health Plus (hereinafter, the device).

The risk management plan will be reviewed and updated at least annually or when required as new information becomes available.

This document is drafted according to the requirements established in the harmonized standard UNE-EN ISO 14971:2020. Medical devices - Application of risk management to medical devices.

Terms and definitions​

  • ACCOMPANYING DOCUMENTATION: materials accompanying a medical device and containing information for the user or those accountable for the installation, use, maintenance, decommissioning and disposal of the medical device, particularly regarding safe use.
  • AFAP: As far as possible
  • BENEFIT: positive impact or desirable outcome of the use of a medical device on the health of an individual, or a positive impact on patient management or public health.
  • HARM: injury or damage to the health of people, or damage to property or the environment.
  • HAZARD: potential source of harm.
  • HAZARDOUS SITUATION: circumstance in which people, property or the environment is/are exposed to one or more hazards.
  • 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.
  • LIFE CYCLE: series of all phases in the life of a medical device, from the initial conception to final decommissioning and disposal.
  • MANUFACTURER: natural or legal person with responsibility for the design and/or manufacture of a medical device with the intention of making the medical device available for use, under his name, whether or not such a medical device is designed and/or manufactured by that person himself or on his behalf by another person(s)
  • MEDICAL DEVICE: instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, 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 medical 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 by means of in vitro examination of specimens derived from the human body and which does not achieve its primary intended action by pharmacological, immunological or metabolic means, in or on the human body, but which may be assisted in its function by such means.
  • OBJECTIVE EVIDENCE: data supporting the existence or verity of something.
  • POST-PRODUCTION: part of the life cycle of the medical device after the design has been completed and the medical device has been manufactured.
  • PROCEDURE: specified way to carry out an activity or a process.
  • PROCESS: set of interrelated or interacting activities that use inputs to deliver an intended result.
  • REASONABLY FORESEEABLE MISUSE: use of a product or system in a way not intended by the manufacturer, but which can result from readily predictable human behavior.
  • RECORD: document stating results achieved or providing evidence of activities performed.
  • RESIDUAL RISK: risk remaining after risk control measures have been implemented.
  • RISK: combination of the probability of occurrence of harm and the severity of that harm.
  • RISK ANALYSIS: systematic use of available information to identify hazards and to estimate the risk.
  • RISK ASSESSMENT: overall process comprising a risk analysis and a risk evaluation.
  • RISK CONTROL: process in which decisions are made and measures implemented by which risks are reduced to, or maintained within, specified levels.
  • RISK ESTIMATION: process used to assign values to the probability of occurrence of harm and the severity of that harm.
  • RISK EVALUATION: process of comparing the estimated risk against given risk criteria to determine the acceptability of the risk.
  • RISK MANAGEMENT: systematic application of management policies, procedures and practices to the tasks of analyzing, evaluating, controlling and monitoring risk.
  • RISK MANAGEMENT FILE: set of records and other documents that are produced by risk management.
  • SAFETY: freedom from unacceptable risk.
  • SEVERITY: measure of the possible consequences of a hazard.
  • STATE OF THE ART: developed stage of technical capability at a given time as regards products, processes and services, based on the relevant consolidated findings of science, technology and experience.
  • TOP MANAGEMENT: person or group of people who directs and controls a manufacturer at the highest level.
  • USE ERROR: user action or lack of user action while using the medical device that leads to a different result than that intended by the manufacturer or expected by the user.
  • VERIFICATION: confirmation, through the provision of objective evidence, that specified requirements have been fulfilled.

Product characterization​

Intended purpose​

Technical features​

Product life cycles phases​

The life cycle phases of the medical device PRODUCT are the following:

  • Realization process
    • Design and development
    • Transfer to production
  • Post-production phase
    • Installation and maintenance
    • Use
    • Decommissioning and disposal

Similar devices and science state​

  • SIMILAR PRODUCT 1, manufactured by COMPANY 1 SL, is a XXX.
  • SIMILAR PRODUCT 2, manufactured by COMPANY 2 SL, is a XXX.
  • SIMILAR PRODUCT 3, manufactured by COMPANY 3 SL, is a XXX.

The state of the art is periodically analysed in the Clinical Evaluation Report (T-015-003 Clinical evaluation report (CER)) and updated according to the Post-Market Surveillance plan (TF-R-007-001 PMS plan), which is evaluated in the Periodic Safety updated report (TF-R-007-003 PSUR).

Assignment of responsibilities and authorities​

This chapter of the risk management plan aims to identify the personnel or functions with responsibility for the execution of specific activities related to risk management.

Responsibilities and authorities​

note

Describe the personnel and responsibilities for each product or products' family. Below is an example.

Design and development phase​

Personnel​

In this phase, the people involved are:

  • Engineer/scientist
  • Quality manager
  • Medical/clinical expert
  • PRRC
Activities​

In this phase, the activities that must be carried out are:

  • Identification and initial assessment of hazards.
  • Implementation of risk control measures.
  • Verification of control measures.
  • Drafting of the initial risk management report.

Transfer to production phase​

Personnel​

In this phase, the people involved are:

  • Operations
  • Supply-chain management
  • Quality manager
  • PRRC
Activities​

In this phase, the activities that must be carried out are:

  • Review of the applicability and correct implementation of all the risk control measures.
  • Any unforeseen risks or any modified risk control measures will be documented in the risk management record.

Installation and maintenance phase​

Personnel​

In this phase, the people involved are:

  • Quality manager
  • PRRC
  • Service engineer/Biomedical engineer/Medical physicist
  • Information analyzer
Activities​

In this phase, the activities that must be carried out are:

  • Analysis of hazards and risk control measures in relation to installation, maintenance, repair, calibration, service and support processes and practices.
  • Analysis of hazards and risk control measures in relation to distribution.
  • Any anomalous trends in security features will be analyzed to determine if corrective or preventive actions should be implemented.
  • The impact of corrective or preventive measures to maintain or increase the safety of the product will be analyzed by incorporating it into the risk management asset.

Use phase​

Personnel​

In this phase, the people involved are:

  • Quality manager
  • PRRC
  • Service engineer/Biomedical engineer/Medical physicist
  • Marketing Manager
  • Information analyzer
Activities​

In this phase, the activities that must be carried out are:

  • Any customer claim that results in changes/corrections to the product will be analyzed to determine its impact on the initial hazards assessment.
  • Market feedback information will be monitored to determine if corrective/preventive actions should be implemented.

Disposal phase​

Personnel​

In this phase, the people involved are:

  • PRRC
  • Quality manager
Activities​

In this phase, the activities that must be carried out are:

  • The useful life will be determined by the Quality Manager.
  • Report of the product will be retained to confirm its correct functionality even at the end of the designated service life.
  • Risk management plan will be closed.

Qualification of the risk management team​

The team performing the risk mangement is comprised by persons with knowledge and experience of not just risk management, but also with knowledge on the medical device, technologies involved and its use.

The responsibilities are defined at the corresponding T-005-001 Job description and the qualification for each of the components is registered in the T-005-002 Personnel card. Additionally, their CVs are documented as independent files and archived within each member personnel file within the human resources tool in use.

note

List all the members of the risk management team according to the following squeme.

Name 1​

  • Job position:
  • Education:
  • Experience with the product/process/technology:
  • Training in risk management and other applicable:
  • Valuation: QUALIFIED
  • Date:
  • Approved by: Name 2 (Job position)

Risk management activities review​

During each phase of the life cycle of the medical device, the personnel in charge of each activity will review the risk management activities. Moreover, a T-013-003 Risk management report is carried out:

  • XXX (indicate periodicity).
  • When a new hazard is identified for which the corresponding control action must be implemented (occasionally).
  • Or when a known hazard requires the redesign of control actions (occasionally).

In any case, a new version of the T-013-002 Risk management record must be created, drafting the new hazards and/or the revaluation of the new conditions of known hazard.

Criteria for risk acceptability​

The acceptability of the risk will be evaluated by means of a qualitative analysis of the casuistry of the ranges of probability and severity of every identified risk, always considering the current state of the art and the available information as existing technology and practice provided. The acceptance of a potential risk will be assessed according to the parameters defined in the general procedure GP-013 Risk management.

As explained in the GP-013, when the probability of occurrence of harm cannot be estimated, the probability will be assigned in terms of detectability.

Evaluation and criteria for individual benefit-risk acceptability and the overall residual risk​

The method to evaluate the criteria for individual benefit-risk acceptability and the overall residual risk considers the clinical benefits provided by the performance of the intended use of the medical device, an it is defined GP-013 Risk management.

The results of the evaluation of the overall residual risk are documented in the R-TF-013-002 Risk Management Record.

Verification activities​

Two different verifications activities required by the harmonized standard UNE-EN ISO 14971:2020 are carried out as defined GP-013 Risk management.

The evidence for verification of implementation and effectiveness of risk control measures are collected in the R-TF-013-002 Risk Management Record.

Collection and review of production and post-production information​

We establish a system to actively collect and review information related to PRODUCT in the production and post-production phases and to review this information for relevance to safety.

These activities are described in the Procedures GP-006 Non-conformity. Corrective and preventive actions, GP-007 Post-market surveillance and GP-014 Feedback and complaints.

Associated documents​

  • T-005-001 Job description
  • T-005-002 Personnel card
  • T-007-001 PMS plan
  • T-007-003 PSUR
  • T-013-002 Risk Management Record
  • T-013-003 Risk management report
  • T-015-003 Clinical evaluation report (CER)
  • GP-004 Vigilance system
  • GP-006 Non-conformity. Corrective and preventive actions
  • GP-007 Post-market surveillance
  • GP-014 Feedback and complaints

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
Previous
Templates
Next
T-013-002 Risk management record_YYYY_nnn
  • Scope
  • Terms and definitions
  • Product characterization
    • Intended purpose
    • Technical features
    • Product life cycles phases
    • Similar devices and science state
  • Assignment of responsibilities and authorities
    • Responsibilities and authorities
      • Design and development phase
        • Personnel
        • Activities
      • Transfer to production phase
        • Personnel
        • Activities
      • Installation and maintenance phase
        • Personnel
        • Activities
      • Use phase
        • Personnel
        • Activities
      • Disposal phase
        • Personnel
        • Activities
    • Qualification of the risk management team
      • Name 1
  • Risk management activities review
  • Criteria for risk acceptability
  • Evaluation and criteria for individual benefit-risk acceptability and the overall residual risk
  • Verification activities
  • Collection and review of production and post-production information
  • Associated documents
  • 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.)