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Quality Management System

As a Class I medical device for diagnostic support, we comply with Risk management standards, as well as Quality management systems and Software life cycle processes for medical devices and usability.

  • ✅ UNE-EN ISO 13485:2016
  • ✅ UNE-EN 62304:2007
  • ✅ UNE-EN ISO 14971:2019
  • ✅ UNE-EN ISO 15223-1:2017
  • ✅ UNE-EN 1041:2009/A1:2014
  • ✅ UNE-EN 62366:2009/A1:2015

We have own Quality management systems at https://qms.legit.health/. (Private access 🔓)

Purpose​

To define and establish a Quality Management System (QMS) that allows and guarantees the compliance of the requirements applicable to our organisation in its area, the design and development of medical software.

The organization​

Description​

We are an European company that proudly designs, develops, produces and commercializes software solutions for care providers.

Identification of the activity​

We are manufacturers of software as medical device to help health care professionals to help their patients through AI applied to dermatology. The medical device currently developed consists of a clinical decision support tool, that is intended to be used in the clinical practice to care for patients with visible skin conditions.

Context of the organization​

We founded our company in 2020. The founders are Sheyla Andina Aguilar Robles, Alfonso Medela, Gerardo Fernández and Taig Mac Carthy. The headquarters are in Bilbao, Spain.

The project was created in the context of an increasing need for digital health, offering a solution to the necessity of a fast, efficient and convenient clinical diagnostic support and a constant and objective monitoring of the severity of the conditions.

Our company is composed of a varying number of employees. The number and roles of employees are defined in the Annex 3 Organisational chart.

Understanding of the organization and its context​

Our context is composed of the following stakeholders (interested parties):

  • The company and its partners, who aim at improving the state of the art of science and collaborating in the technological evolution of diagnostic support and severity assessment of skin conditions.
  • The employees, whose requirements are the engine of technological value to improve people's health, together with their personal and professional evolution and satisfactory financial remuneration.
  • The health authorities that evaluate if the solution is safe and effective to be available for their users.
  • The patients, patients' associations and general population who, being affected by skin pathologies, wish to have an effective tool for monitoring their condition.
  • The customers, consisting of healthcare providers, who aim at improving the health of their patients.

Mission​

Our mission is documented together in the Annex 1 Quality policy.

Vision​

Our vision is documented together in the Annex 1 Quality policy.

Organization role​

Our role is that of legal manufacturer of medical device softwares for skin conditions diagnosis support and follow up.

Applicable regulation and standards​

The applicable regulation is the Regulation (EU) 2017/745 of the European Parliament and of the Council on Medical Devices.

To create and maintain our QMS we have followed the standards:

  • UNE-EN ISO 13485:2016 Medical devices. Quality management systems. Requirements for regulatory purposes.
  • ISO 14971:2020 Medical devices.Application of risk management to medical devices

Other applicable standards, legislation and regulations specific for each medical device or family of medical devices are specified at each product description and specification document.

ISO 13485:2016 standard non-applicable requirements​

  • 7.5.2 Cleanliness of the product: due to its nature of medical device software, it does not require cleaning.
  • 7.5.3 Activities during installation: due to its nature of medical device software, it does not require a physical installation, but a service provision.
  • 7.5.5 Particular requirements for sterile medical devices: due to its nature of medical device software, it is not a sterile product.
  • 7.5.7 Particular requirements for the validation of sterilization processes and sterile barrier systems: due to its condition of non-sterility.
  • 7.5.9.2 Particular requirements for implantable medical devices: due to its nature of medical device software, it is not an implantable product.
  • 7.6 Control of the monitoring and measuring equipment: due to its nature of medical device software, it is not required for follow-up in terms of measuring.
  • 8.3.4 Re-work: due to its nature of medical device software.

Quality management system (QMS)​

General requirements​

We have established, documented and implemented a Quality Management System (QMS) with the aim to constantly improve our effectiveness and efficiency on our software as medical device manufacturing processes, enabling our products to achieve the expectations of the Annex 1 Quality policy and satisfy the customer and regulatory requirements.

The implanted QMS standardizes the processes in all our activities to ensure consistency in providing quality and safe services to its customers. Our management ensures the availability of the resources and information necessary to support the monitoring of the processes. The use of self-assessments, data analysis, verification activities and review management ensure that the QMS is effective, as it is described in the procedure GP-002 Quality planning.

The adoption of a QMS is a strategic decision. Likewise, its design and implementation is influenced by varying needs, objectives, planned projects, employed processes, and size and structure of the organization.

Finally, our QMS:

  • Demonstrates its ability to consistently provide medical devices that comply with the applicable regulatory and customer requirements.
  • Aims at its effective application, including the processes for continuous improvement and the assurance of conformity with the applicable regulatory and customer requirements.
graph LR A[Quality Manual and Annexes] <--> B[General procedures GP-XXX] B<-->C[Specific procedures SP-XXX] C <--> D[Customer documentation, Records, templates and reports, <br/>Technical documentation and any other type <br/>of documentation requested by the regulation]

All the internal documentation originated in the QMS is interconnected, every general procedure contains its related documentation such as other procedures, records and reports.

We have a general procedure to control and unify the formats and criteria for the preparation of all the documentation related to the QMS that is the GP-001 Documents and records control.

Quality manual​

We implemented and maintains this Quality Manual that includes the following annexes:

Annex 1 Quality policy​

Document that details the commitment of the management with the development, implementation and improvement of the QMS.

Annex 2 Processes map​

Document where it is established a diagram that graphically describes all our processes and their relation and coordination.

Annex 3 Organisational chart​

Document that describes the different job descriptions and roles establishing their relationship with the personnel, and the corresponding subtitutes for each role.

procedures and records​

The general procedures we have in place are the ones listed below. Their current version and approval date can be consulted in the documents themselfs or at the R-001-001 Control of documents and records.

They contain all the procedures required for the QMS, manufacturing process and data protection, and we have also created, when required, detailed specific procedures of some specific processes and the corresponding records for both, the general and specific procedures. We compile a list of all of these documents at the R-001-001 Control of documents and records.

  • GP-001 Documents and records control
  • GP-002 Quality planning
  • GP-003 Internal audit
  • GP-004 Vigilance system
  • GP-005 Human resources
  • 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
  • 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
  • GP-020 Data analysis
  • GP-021 Communications
  • GP-022 Documentation translation
  • GP-023 Design change control
  • GP-050 Data protection
  • GP-051 Security violations
  • GP-052 Data Privacy Impact Assesment (DPIA)
Documents control​

All our documents are controlled and archived as a special type of documents according to the requirements implanted in the QMS, that are described in the procedure GP-001 Documents and records control, where the responsibilities for each document are also detailed.

Records control​

We maintain all the records required by our QMS to provide evidence of control and conformity of the effective operation. They are controlled according to the requirements implanted in the QMS, that are described in the procedure GP-001 Documents and records control, where the responsibilities for each document are also detailed.

External documentation​

We also maintain a file with the external documentation we need to consider, mainly coming from regulations and standards applicable to our company and the products we manufacture, but they can also come from customers, health authorities, notified bodies or any other interested party. The management of this documentation is detailed at the procedure GP-001 Documents and records control.

Technical documentation​

For our medical devices, we establish and maintains files either containing or referencing documents generated to demonstrate conformity with the harmonized standard UNE-EN ISO 13485:2018 and to comply with the applicable regulatory requirements, 93/42/EEC MDD for the Class I product and 2017/745 MDR for the Class IIa product. This control is established and described in the procedure GP-001 Documents and records control.

Technical File (TF)​

We will prepare one Technical File for each medical device or family of medical devices manufactured that will contain, at least:

  • Product name and a general description of the device including its lifetime, intended environment, intended purpose and intended users.
  • Basic UDI-DI assigned by the manufacturer
  • The targeted patient population and medical conditions to be diagnosed, treated and/or monitored and other considerations such as patient selection criteria (inclusion/exclusion), indications, contra-indications and warnings.
  • Principle of operation of the device
  • Rationale for the qualification of the product as a medical device.
  • The risk class of the device and the justification for the classification rules applied in accordance with Annex VIII of MDR 2017/745.
  • The conformity assessment route.
  • Explanation of any novel features.
  • Description of the device accessories and other products which are intended to be used in combination with it.
  • Description of the different configurations/variants of the device.
  • General description of the main functional elements, e.g., its parts/components (including software if appropriate), its formulation, its composition, its functionality and, where relevant, its qualitative and quantitative composition. Where appropriate, this shall include labelled pictorial representations (e.g., diagrams, photographs and drawings), clearly indicating key parts/components, including sufficient explanation to understand the drawings and diagrams.
  • Technical specifications, such as features, dimensions and performance attributes of the device.
  • Product history including previous generations, novel features and other similar devices on the market.
  • Label and information to be supplied by the manufacturer.
  • Design, redesign and manufacturing information.
  • General safety and performance requirements.
  • Benefit-risk analysis and risk management.
  • Product verification and validation.
Non-applicable due to software nature
  • Description of any consumables associated with the device.
  • Characterization of the raw materials.
  • Sterilization information
Design History File (DHF)​

One specific and important section of the TF is the Design History File (DHF), where we document all the data related to the design and development process, according to the requirements of the harmonized standard(s). It will contain, at least:

  • Technical specifications
  • Design planning
  • Design inputs
  • Design outputs
  • Design review
  • Design verification
  • Design validation
  • Design charge record

The DHF characteristics and usage is detailed at the GP-012 Design, redesign and development procedure.

Labeling and Instructions For Use (IFU)​

We will prepare the labeling and IFU in accordance with Annex I of MDR 2017/745 section 23.

EU Declaration of Conformity (DoC)​

We will prepare a DoC for each medical device or family of medical devices manufactured in accordance with the Annex IV of the MDR 2017/745.

Management responsibility​

Management commitment​

The management is totally committed with the development, implementation and maintenance of the effectiveness of the QMS. The necessary tasks to control, document and review these requirements are exposed in the procedure GP-002 Quality planning.

Customer focus​

The management, together with the rest of the personnel involved in the tasks of the organization, is responsible to ensure that the applicable customer and regulatory requirements are determined and accomplished by controlling and monitoring actions.

Quality policy​

In the Annex 1 Quality policy, we detais the commitment of the management with the development and implementation of the QMS, as well as the continuous improvement of its effectiveness.

The management establishes the necessary measures to ensure that the communication of the quality policy in all the areas of the organization is understood, applied, revised and updated. The specific objectives of the organization and its key elements to comply with what is defined in its quality policy are defined, allocating to each department the necessary authority and responsibility, putting at its disposal the possible human, technical and economic resources for the compliance with the objectives and the effectiveness of the system.

We establish a procedure to ensure that the quality is reviewed at least once a year for the continuous suitability as it is described in the procedure GP-002 Quality planning.

Planning​

Quality objectives​

The management establishes the protocol of the objectives' set up and follow up (T-002-002 Quality objectives) in the procedure GP-002 Quality planning. Each quality objective is measurable and consistent with the Annex 1 Quality policy and considers its correspondence with applicable legislation and client requirements.

Quality Management System planning​

We establish the quality planning through the procedure GP-002 Quality planning to meet the requirements of the QMS when changes are planned and implemented. When a significant change in the QMS is considered necessary, it is monitored and evaluated through the activities described in said procedure.

Organizational structure​

We have planned an organizational structure of its personnel established in the Annex 3 Organisational chart. The experience, knowledge and responsibilities for each position are defined in the corresponding T-005-001 Job description.

The activities related to the training actions and the methodology implanted to satisfy the needs to accomplish with the personnel competence requirements are described in the procedure GP-005 Human resources.

Philosophy of the organization​

As we have previously mentioned, the Annex 1 Quality policy defines the philosophy regarding quality. The managment approves it and communicates it to the personnel.

Processes structure​

The organization of the activities performed is established through the process vision. In the Annex 2 Processes map is defined the sequence of the different processes and and their relation and coordination.

Responsibility, authority and communication​

Responsibility and authority​

The human structure of the organization is described through the Annex 3 Organisational chart, which indicates the hierarchical and functional relationships that exist between the different job positions established. In each case, the management ensures that the responsibilities and authorities are defined, documented and communicated through each employee onboarding process, accurately revised and promoting the necessary activities described in this Quality Manual.

With the aim to ensure the correct performance of the activities, in the Annex 3 Organisational chart it is included the substitution table where it is described the relationship of available substitutes for each job position that are duly qualified in accordance with the verifications described in the procedure GP-005 Human resources.

Management representative​

The JD-004and JD-005PRRC are the representatives designated by the CEO in quality and regulatory affairs, which independently of other responsibilities have the authority to:

  • Ensure that the processes of the QMS are established, implemented and maintained.
  • Report to the management about the performance of the QMS and any need for improvement.
  • Ensure the promotion of knowledge of legal and regulatory and client requirements throughout the whole organization.

Internal communication​

The JD-001 ensures that the appropriate communication processes are established through the activities described in this Quality Manual and the procedures and external documentation added to the QMS. Likewise, the CEO promotes the horizontal and vertical diffusion of knowledge, especially all the information related to the Annex 1 Quality policy and the T-002-002 Quality objectives to the internal and external personnel involved with our medical devices.

The personnel’s feedback is encouraged with the aim to continuously improve, as well as any other significant information involved with the QMS. In the same way, when it is carried out a management review, the conclusions are disseminated to the personnel and the organization uses the training activities to share all this information.

The following communication means are planned:

  • Email
  • Telephone call and/or videoconference
  • Slack
  • Periodic team buildings meetings

External communication​

The principles and limits in communications with clients and other commercial and clinical operators are defined in the Procedure GP-021 Communications, ensuring that in the label, instructions for use, commercialization, putting into service and advertising of devices, it is not used texts, names, trademarks, pictures and figures or other signs that may mislead the user or the patient regarding the device's intended purpose, safety and performance.

Management review​

The QMS is reviewed by the management to ensure its suitability, adequacy and effectiveness in accordance with the procedure GP-002 Quality planning. The review includes the associated risks evaluation and the assessment of opportunities for improvement and need for changes of the QMS, including the Annex 1 Quality policy and the T-002-002 Quality objectives. This review is performed at least once a year as it is registered at the R-002-005 Quality calendar.

Resources management​

Provision of resources​

In all the activities we develop we determine and provide the resources needed to implement the QMS and to maintain its effectiveness as well as to meet the applicable regulatory and customer requirements.

Human resources​

The JD-001, with the department involved, defines the qualification requirements of the job positions to ensure that all personnel are competent to develop the assigned activities. The priorities and planning of the training activities are described in the procedure GP-005 Human resources. Each department has the responsibility of knowing and applying the QMS in general terms and the procedures related to their job in a comprehensive manner.

The CEO ensures that the personnel are aware of the relevance and importance of their activities and how they contribute to the achievement of the T-002-002 Quality objectives.

Training plan​

In the T-005-003 Training plan we record the activities carried out by the personnel to obtain the required skills to accomplish their assigned tasks, when it is detected that they are necessary for the fulfilment of the objectives, as it is described in the procedure GP-005 Human resources.

Training evaluation​

Once the training activities have been completed, the supervisor of each employee evaluates the results and the benefit for us, recording the results in the T-005-004 Training evaluation and record as it is described in the procedure GP-005 Human resources.

New personnel entry​

We have an onboarding procedure implemented described in the GP-005 Human resources to allow the new employee an smooth, agile, guided entry to the company and the daily routine, the procedures, the enviroment, the QMS and other activities, trainings and information relevant to their work.

Infrastructure​

The JD-001 of the company identifies and provides the necessary infrastructure (equipment and facilities) to comply with the requirements of the products we develop.

The JD-003 or designee maintains the equipment and facilities in the proper conditions, designing and applying the T-018-001 Infrastructure list and control plan.

We document within the QMS the maintenance activities when these can affect the product quality as it is described in the procedure GP-018 Infrastructure and facilities.

Work environment and contamination control​

Our work environment should be harmonious and pleasant. The employee satisfaction becomes a clear objective for the company.

Furthermore, we provide the appropriate measures to ensure a work environment that allows compliance with the requirements of our products. In all the areas of the company, order and cleanliness are considered of utmost importance during the performance of the service to maintain the proper conditions for the personnel, not directly affecting the product features nor quality, as well as the compliance with the current legislation on Occupational Safety.

In the procedures GP-011 Provision of service and GP-018 Infrastructure and facilities, we describe the specifications of the preservation and control of the medical device, as well as all the protocols related to the order and cleanliness of our facilities and our suppliers and subcontractors.

We do not have working facilities, but the registered office that can be used by the personnel that requires it. Due to the nature of our activities, we have validated that our work style is the remote one at the corresponding R-002-007 Process validation card 2023_005.

Product development​

Product development planning​

We have both the necessary personnel and means to implement and maintain the effectiveness of the QMS and to comply with the applicable regulatory and customer requirements.

The necessary resources to cover all the internal needs and meet the quality objectives are determined in the procedure GP-012 Design, redesign and development.

Also, we determine the requirements for the risk management throughout the product development keeping the records resulting from the management following the procedure GP-013 Risk management.

The activities of verification, monitoring, inspection, storage, distribution and traceability specific to the products, as well as the criteria for their acceptance are determined according to the procedures GP-012 Design, redesign and development, GP-011 Provision of service and GP-016 Traceability and identification.

We determine the clients’ requirements including those of delivery and post-delivery activities, the already known requirements not declared by the client but necessary for its intended use, the applicable regulatory requirements related to the product, any use training needed to ensure the product performance or any other requirement established in the production, according to the procedure GP-009 Sales.

This review is established before committing to supply and ensuring that the requirements, both legal and requested by the client, are defined and documented and that we can comply with the supply of the product in a satisfactory way, according to the procedures GP-008 Product requirements and GP-009 Sales.

Communication​

We identify and implement the provisions for communicating with the customers about the product information, solving the queries that arise, processing the corresponding orders that are received and their modifications, in accordance with the procedure GP-009 Sales.

We also establish the procedure to collect customer feedback including the different types of complaints according to the procedure GP-014 Feedback and complaints. In the case that it is necessary to take actions, it will be done according to the procedures GP-004 Vigilance system and/or GP-006 Non-conformity. Corrective and preventive actions.

Design and development​

All the relevant actions (planning, inputs, outputs, revision, verification, validation, transfer and changes control) for the design and development of new products are documented following the procedure GP-012 Design, redesign and development with the aim to complete the design files of each product developed.

Purchases​

Purchasing process​

The purchasing system we use for the acquisition of products and services is based on the evaluation of the suppliers and materials or services, ensuring compliance with the established specifications as it is described in the procedure GP-010 Purchases and suppliers’ evaluation.

The materials or services we purchase are periodically verified upon receipt as described in the procedure GP-010 Purchases and suppliers’ evaluation to ensure that they meet the specified purchase requirements.

Production and service provision​

Control of production and service provision​

Due to the nature of our products as a standalone softares, the production phase of the device does not start when a client request the product, but the product is already developed, tested, validated and released according to the GP-012 Design, redesign and development.

When a new contract is signed according to the procedure GP-009 Sales, we start the service provision to the client as we have described at the GP-011 Provision of service procedure.

Product cleanliness​

note

This requirement is not applicable because we only produce software.

Activities during installation​

note

This requirement is not applicable because we only produce software.

Technical Assistance Services​

We carry out the Technical Assistance Services (SAT) and the verification of the product requirements compliance in accordance with the procedure GP-017 Technical Assistance Service.

Particular requirements for sterile medical devices​

note

This requirement is not applicable because we only produce software.

Validation of the production and service provision processes​

We document the pre-validation of the processes in the T-002-007 Process validation card corresponding to the initial definition or modification of the processes.

We have designed a system for products and services measuring, data from which is deduced the variation or necessity for actions to correct non-conformities, through the T-002-003 Quality indicators.

Particular requirements for the validation of sterilization processes and sterile barrier systems​

note

This requirement is not applicable because we only produce software.

Identification and traceability​

The identification and traceability of the product is documented throughout the planning, purchasing, production, storing, distribution and removing phases, following the procedure GP-016 Traceability and identification.

Particular requirements for implantable medical devices​
note

This requirement is not applicable because we only produce software.

Customer property​

We seek to identify, verify, protect and safeguard the client's property while it is under the control of the organization.

Customers’ personnel data is the customers’ property, and consequently we have implemented and certified a specific methodology to maintain its safety throughout the GP-050 Data protection procedure.

When any property of the client is lost, deteriorates or in some way becomes inappropriate for its use, the relevant records are communicated and maintained.

Product preservation​

Our resources allow the correct preservation of the products we develop.

We prepare the necessary means to host the information and databases according to the current standards and we ensure the safety of the data, maintaining relationships with the suppliers of hosting service, which are verified, evaluated and accepted according to the procedure GP-010 Purchases and suppliers’ evaluation.

Control of the monitoring and measuring equipment​

note

This requirement is not applicable because we only produce software.

Measurement, analysis and improvement​

General provisions​

We plan and implement the monitoring, measurement, analysis and improvement processes to demonstrate compliance with the product requirements, ensure the conformity of the QMS and continuously improve its effectiveness.

Surveillance and measurement​

Feedback​

As a measure of the effectiveness of the QMS implanted we obtain information of the accomplishment of the client requirements and to gain specific experience in the post-production phase, following the procedures GP-007 Post-market surveillance and GP-014 Feedback and complaints.

This information serves as a potential input to the risk management for the monitoring and maintenance of the applicable product requirements, both legislative and customer.

Claim management​

The claims process in accordance with the applicable regulatory requirements is documented in the procedure GP-014 Feedback and complaints, along with proactive research of the customer experience feedback.

Notification to the regulatory authorities​

In the case that the regulatory requirements require the notification of claims that meet the specific criteria of adverse incidents, we will notify the appropriate regulatory authorities following the GP-004 Vigilance system procedure.

Likewise, the records of the notifications made are kept and any withdrawal of the product from the market is carried out as described in the procedure GP-004 Vigilance system.

Internal audit​

The audits are carried out to determine if the QMS complies with the planned provisions, with the requirements of the standard UNE-EN ISO 13485:2018 and with the requirements of the QMS we have implemented.

The JD-004 manages the R-003-001 Audit program according to the procedure GP-003 Audits for the verification and monitoring of the correct implementation of the QMS.

Monitoring and measurement of processes​

With the information provided by the T-002-003 Quality indicators associated with the different processes, these are measured and monitored to demonstrate their ability to achieve the planned results.

The indicators are defined for each process an managed by the owner of the process as it is described in the procedure GP-002 Quality planning and the record itself. When the monitoring of these indicators shows the inability of the process to achieve the planned results, the necessary actions must be taken according to the procedure GP-006 Non-conformity procedure. Corrective and preventive actions.

Requirements for setting indicators:​
  • At least 2 indicators per process.
  • A color code to show if the process is under control (GREEN) or not (RED).
  • They are based on a mathematical formula.
  • A planned review date, by quarter, semester, or year.
  • Storage of historical data.
  • Graphic representation of trends.

Monitoring and measurement of product​

We establish a series of verifications in the appropriate phases of the development process of the product to verify that the product requirements are met. The verifications are carried out as described in the procedure GP-012 Design, redesign and development.

Non-conforming product management​

General provisions​

AWe have established the methodology to identify and control the products that do not comply with the applicable requirements. The procedure GP-006 Non-conformity. Corrective and preventive actions defines the controls and responsibilities for the identification, documentation, segregation or immobilization, evaluation and disposition of nonconforming products, maintaining records of any subsequent action taken.

Actions in response to the non-conforming product detected before delivery​

The actions to be taken when a non-conforming product is detected before delivery are described in the procedure GP-006 Non-conformity. Corrective and preventive actions.

Actions in response to the non-conforming product detected after delivery​

The actions to be taken when a non-conforming product is detected after delivery are described in the procedure GP-006 Non-conformity. Corrective and preventive actions.

Re-work​

note

This requirement is not applicable because we only produce software.

Data analysis​

We establish the methodology to determine, collect and analyse the appropriate data to demonstrate the suitability, adequacy and effectiveness of the QMS, in addition to the methods used as statistical techniques, as it is described in the procedure GP-020 Data analysis.

In case that these data demonstrate that the QMS is not convenient, adequate or effective, it would be used as a starting point to improve the QMS.

Improvement​

General provisions​

We identify and apply the necessary changes to guarantee and maintain the continuous suitability, adequacy and effectiveness of the QMS, as well as the safety and performance of the medical devices developed by using the quality policy, the quality objectives, the results of audits, the post-market surveillance, the data analysis, the corrective and preventive actions and the management review.

To plan the continuous improvement, we establish working groups when required to:

  • Identify improvement points or problems of the processes to be improved.
  • Analyse the main causes of the problem through quality improvement tools.
  • Evaluate alternatives and select more appropriate actions.

The JD-001 determines the application of the proposed actions, incorporating them in the quality plan or establishing specific corrective actions.

The management provides the necessary resources to ensure that the actions taken are incorporated into the work or process systematics to ensure that improvements are maintained.

Corrective action​

We define the methodology to implement the necessary corrective actions in case of non-conformity in the procedure GP-006 Non-conformity. Corrective and preventive actions.

Preventive action​

We define the methodology to implement the necessary preventive actions in case of non-conformity in the procedure GP-006 Non-conformity. Corrective and preventive actions.

Software validation​

The systematic process for the validation of the software we use is described in the Procedure GP-019 Software validation.

Post-market surveillance​

The post-market surveillance is integrated in the QMS under the procedure GP-007 Post-market surveillance.

Clinical evaluation​

The clinical evaluation of the product is integrated in the QMS under the procedure GP-015 Clinical evaluation.