Quality Manual

Purpose

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

Scope of the quality management system

Design, development and commercialisation of medical device software.

note

This is a temporary scope pending confirmation with our Notified Body.

The organization

Description

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

Identification of the activity

We manufacture software as a medical device to aid healthcare practitioners and organizations in their clinical decision-making process, thus enhancing the efficiency and accuracy of care delivery.

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 ICD classes.

Context of the organization

We founded our company in 2020 after years of research and prototyping. The founders of the company are Andy Aguilar, 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 of employees and their roles are defined within the existing human resources tool, as described in our GP-005 Human Resources and Training.

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 the general population who are affected by visible conditions, and 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

We are legal manufacturers of medical device software for clinical decision support.

Applicable regulations and standards

The applicable regulation is the Regulation (EU) 2017/745 of the European Parliament and of the Council on Medical Devices and the Spanish Royal Decree 192/2023 regulating the medical devices.

To create and maintain our QMS we follow 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 in 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.
• 7.5.10. Customer property: due to its nature of medical device software, it is not applicable.
• 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

The documentation of our QMS is structured in hierarchical levels as it is described in the figure below, wherein the criteria of the higher-level documentation prevails.

QMandAnnexes

General Procedures

Specific Procedures

Customer documentationRecords, templates and reportsTechnical documentationany other regulatory documentation

We have established, documented and implemented a Quality Management System (QMS) to constantly improve our effectiveness and efficiency of 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 described in the procedure GP-002 Quality planning.

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

All the internal documentation originating 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 which is the GP-001 Documents and records control.

Quality manual

We implemented and maintain 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.

Organizational chart

The different job descriptions and roles establishing their relationship with the personnel are defined by our human resources tool, following GP-005 Human Resources and Training.

Annex 4 Substitution table

In this document, we detail the substitutes for each role so that each employee knows the person responsible for covering their activities during an absence.

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 themselves or at the R-001-001 Control of documents.

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 we review it according to the established frequency.

Documents control

All our documents are controlled and archived as a special type of document according to the requirements implanted in the QMS, which 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 with 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 in 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.

Label and Instructions For Use (IFU)

We will prepare the label 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. We perform weekly meetings with all personnel to discuss new possible customer requirements, to discuss their feasibility and to manage properly the resources to achieve them.

Quality policy

In the Annex 1 Quality policy, we detail 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 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 for our staff as shown in human resources tool's Organizational 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 to accomplish the competence requirements of our personnel 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 management approves it and communicates it to the personnel.

Processes structure

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

Responsibility, authority and communication

Responsibility and authority

The human structure of the organization is described through the Organisational chart which can be consulted in our human resources tool (defined in GP-005 Human Resources and Training), 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.

To ensure the correct performance of the activities, in the Annex 4 Substitution table we describe 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-004 and JD-005 PRRCs are the representatives designated by the JD-001 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, 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 JD-001 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 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
• Corporate internal messaging
• Periodic team building 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. The procedure ensures that the label, instructions for use, and advertising of devices, do not use texts, names, trademarks, pictures and figures or other signs that may mislead the user 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 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 JD-001 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 our personnel to obtain the required skills that enable them to fulfill their roles, as 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 described in the procedure GP-005 Human resources.

New personnel entry

We have an onboarding procedure. The onboarding procedure is described in GP-005 Human resources and it is designed to facilitate new employee a smooth, agile, and guided entry to the company. It introduces them to the daily routine, the procedures, the enviroment, the QMS and other 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, JD-007 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 described in the procedure GP-018 Infrastructure and facilities.

Work environment and contamination control

Our work environment should be harmonious and pleasant. Employee satisfaction is a major objective for the company. Furthermore, we especially emphasize and protect work-life balance, especially for employees with children. To that effect, we allow and encourage remote working.

Indeed, we do not use in-person facilities as a norm, but the registered office can be used by the personnel that require 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. Thus, we do not require protocols related to the order and cleanliness of our facilities and our suppliers and subcontractors. We train our employees on proper workplace conditions at the start of their work activity, together with training on health risk prevention.

In general, 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. This is true both for physical spaces, and for virtual spaces.

As we manufacture software as medical device, we describe the specifications of the preservation and control of the products in GP-012 Design, redesign and development.

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 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.

Customer-related processes

Determination of the requirements related to the product

We meticulously ascertain the client's requirement, encompassing both delivery and post-delivery operations, and identify the established but unexpressed requirements that are crucial for the product's intended functionality. Additionally, we take into account all pertinent regulatory requirements associated with the product, as well as any training on its use that is essential to guarantee optimal product performance. We also consider any other requirement determined during the production process. All of these elements are evaluated and managed in accordance with the protocols outlined in GP-008 Product requirements and GP-009 Sales.

This comprehensive approach ensures a thorough understanding and fulfillment of the client's needs, fostering product satisfaction and compliance.

Review of the requirements related to the product

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 proactively identify and put into action the required measures for engaging with customers, facilitating the exchange of product information, addressing any emerging queries, processing incoming orders, and managing any necessary modifications to those orders. All these tasks are meticulously carried out in alignment with the guidelines set forth in GP-009 Sales and GP-021 Communications, ensuring a seamless and responsive customer interaction experience.

In tandem, we have developed a robust procedure to systematically gather customer feedback, which encompasses various types of complaints, as delineated in GP-014 Feedback and complaints. Should the need arise to initiate corrective or preventive actions based on the feedback received, we are prepared to do so in strict accordance with the procedures outlined in 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 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 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 software, 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

note

This requirement is not applicable as we do not manage customer properties.

Product preservation

Our resources allow the correct preservation of the products we develop according to our GP-012 Design, redesign and development procedure.

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.

Complaints management

The complaints 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 complaints 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 procedures GP-004 Vigilance system and SP-004-001 Product withdrawal.

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 and managed by the owner of the process as 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 colour 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

We 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 described in the procedure GP-020 Data analysis.

In case 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 into the QMS under the procedure GP-015 Clinical evaluation. If any clinical investigation is required it will be performed according to this procedure following the ISO 14155 Clinical investigation of medical devices for humans. Good clinical practices.

Signature meaning

The signatures for the approval process of this document can be found in the verified commits at the repository for the QMS. As a reference, the team members who are expected to participate in this document and their roles in the approval process, as defined in Annex I Responsibility Matrix of the GP-001, are:

• Author: Team members involved
• Reviewer: JD-003, JD-004
• Approver: JD-001