R-002-004 Annual management review report_2023_001

Meeting details

Assistants

Name	Position	Signature
Andy Aguilar	General Manager	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
Taig Mac Carthy	Design & Development Manager	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
Alfonso Medela	Technical Responsible & PRRC	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
María Diez	Quality Manager & PRRC	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

Place

On-line

Date

February 22, 2023

Inputs

Company context, quality policy and objectives review

SWOT and CAME analysis

SWOT and CAME analysis has been performed and recorded at the R-002-006 SWOT and CAME analysis_2023_001.

The most important weaknesses and threads detected come from the fact that the company is very young, the team is still small and that our activity requires us to adapt and comply to many different regulations, but we have a differential and validated value proposition and the team is really compromised, with deep knowledge on this value and making an effort on, not only compling with the regulatory requirements, but also with improving our tools to increase the productivity and knowledge. We know that our field has a lot of opportunities for us, as there is a reduced number of specialists in a growing demand scenario.

From these findings we have decided that we are going to improve the following main aspects:

• Better organization and improve the process of the business development (already ongoing)
• Improve the team: To hire more specialized team and to improve leadership including more experts leading the different departments.
• Explore new financial sources
• Sign a contract with a NB and have all the documentation prepared for the new MDR regulation (Objectives 1 & 2)
• Explore the requirements to obtain the FDA approval to establish the best strategy.
• Register our product at the MHRA (Objective 6)

Quality policy

The Quality Policy Annex_1_Quality Policy version 2 was reviewed and approved on 2022/09/23 with no significant changes with respect to the previous one. A new version (3) was released last 2023/02/17 including a signature table at the end to distribute it to the employees and allow them to sign it.

Quality objectives

2022 objectives are reflected at the R-002-001_Quality objectives list_22_001

1. Certify with a Notified Body the new Class IIa medical device. This objective has been 60% achieved. Notified bodies have a high waiting list due to the new European regulations for the MD and IVD. We are taking advantage of this to improve the QMS in place and all the documentation required.

2. Certification of the AI LABS GROUP's QMS under EN-ISO-13485 by a Notified Body This objective has been 70% achieved. In addition to the bottleneck of the NBs, we were not enough personnel to complete the task. A new QM was hired to lead the project, and an internal audit was performed at the end of the year.

For the new period, 2023, we have improved the objectives management to ensure all the objectives established maintain a proper follow up to be achieved:

• We have included strategy objectives to this management
• We have implemented a new record (T-002-002_Quality objectives) for each single objective to ensure we cover and follow all the activities related to each objective.

The new objectives that we have established for the 2023 period are reflected at the R-002-001_Quality objectives list_2023_001:

1. Certify with a notified body the new Class IIa medical device
2. Certification of the AI LABS GROUP's QMS under EN-ISO 13485 by a Notified Body
3. Complete the transition to the QMS Legit.Health
4. Increase in turnover by 220 %
5. Product meets customer expectations
6. MHRA registration (UK market access)

Feedback

We receive feedback from our clients/users by different ways:

1. Direct consults through email, phone calls or contact form at the webpage or medical device. All of them are registered at our tickets management tool (Hubspot) in accordance with the general procedure GP-014 Feedback and complaints. During this period the most common feedback obtained through this channel has been related to difficulties during the first use of the application. All of them were properly solved and as a result we have improved the product education to the clients before they started using it. Additionally, we are using this information to improve the IFU of the product during the following months. Annually we also review the number of technical assistances incidences registered (R-002-002_Quality indicators Indicator 19) to ensure they are not increasing dangerously. During 2022 the number of this kind of incidences increased compared to the previous year as expected (16 technical incidences in 2022 vs 7 in 2021), as the number of users also increased (Indicator 9 of R-002-002_Quality indicators: 14 new contracts signed with various users per contract).
2. The most frequent feedback obtained from our customers come from direct meetings with them during their education on the usage of the product, or during the follow up meetings. Their suggestions are shared with the team to study the availability of the implementation of them. During the last period reviewed the following improvements had been performed:
   • Bounding boxes feature included to allow the practicioners to ensure the lesions detected really are lesions and validate them, or modify, delete or create new ones.
3. Surveys performed periodically to know the customer satisfaction/experience and measured as NPS (Net Promoter Score). Last period reviewed (2022) we improved the NPS value registered in 30%. Additionally, one of the objectives established for the 2023 period (Objective 5) includes this surveys results follow up to achieve a higher customer satisfaction.
4. Surveys performed at the end of the clinical studies (see R-002-002_Quality objective_2023_005) to know the satisfaction of the users during the study. During 2022 we performed one survey to the practiciones participants of one of our clinical trials, the one being performed in colaboration with Torrejón Medical Centre. The general satisfaction of the practicioners was positive, they all thought that Legit.Health helped them on the resources optimization, and most of them thought it was a good tool to perform patients triage, that the information provided is quick and usefull and it could be used as a diagnosis support tool. However, one doctor thought the tool was not useful at that time as the quality of the images was not under control. We used this information received to review our "DIQA (Dermatology Image Quality Assessment)" and improve its operation to achieve better quality images to be processed by the algorithm.

Treatment of claims or complaints

The processing of claims by customers is carried out in accordance with the general procedure GP-014 Feedback and complaints. We review annually the number of customer complaints (R-002-002_Quality indicators Indicator 33) to ensure they are not increasing dangerously. There have been 1 customer claim during the year 2022 that resulted in a customer missunderstanding of the output provided by Legit.Health.

Notifications to regulatory authorities

During this period there have been no communications or notifications to the Competent Health Authority.

Audits

External audits

During 2022 two external audits as suppliers have been performed.

Alira Health

Our client Almiral audited us last July 2022 to qualify us as to participate in a clinical trial. They found 6 observations:

• 2 critial observations
• 4 major observations

All of them were treated according to our procedure GP-006 Non-conformities. Corrective and preventive actions (see below at Non-conformities. Corrective and preventive actions section for details) and our responses and evidences were sent to the auditors, but they did not find our QMS as robust as they require for the clinical trial.

We took advantage of the observations performed by them to improve our QMS and to have it prepared for the following projects, and it worked properly as the following audit performed to participate in a clinical trial (see next section) was satisfactory.

ICON

FDAQRC, on bahalf of ICON, audited us last November 2022 to qualify us as a vendor to participate in a clinical trial. They found the following observations:

• No critial observations
• 1 major observation
• 1 minor observation
• 1 "Other" observation

All of them were treated according to our procedure GP-006 Non-conformities. Corrective and preventive actions (see below at Non-conformities. Corrective and preventive actions section for details) and our responses and evidences were sent to the auditors, and the audit was successfully closed.

Internal audits

Last week of November an internal audit to our ISO 13485 QMS that rules the medical device manufacturing procedures was performed (R-003-004_Internal audit report_22_001) with the following findings:

• 9 non-conformities were found (see below at the corresponding Non-conformities. Corrective and preventive actions section)
• 7 opportunities for improvement (see below at Recommendations for improvement section)
• 6 observations, that were treated as preventive actions (see below at Non-conformities. Corrective and preventive actions section)

The grade of conformity of our QMS after the internal audit was satisfactory and the auditor indicated that we comply with the requirements established in the ISO 13485 standard.

Monitoring and measurement of processes

Quality indicators review

As it is described at the GP-002 Quality planning procedure we monitor our processes periodically and register this follow up at the T-002-003 Quality indicators record.

The indicators corresponding to the 2022 period are registered at the R-002-003_Quality indicators_2022_001. During this period all of our process were successfull, as all of the values measured for the indicators complied with the targets established, but two of them related to the Quality Management area:

• Indicator 31, Number of quality non-conformities. This value was higher than expected as we had 2 external audits as vendors during the last year related to clinical trials, that resulted in some non-conformities related to Human Resources procedures that we had not documented in our QMS, and others that were related to procedures not registered according to our QMS. We registered the evidences of the procedures performance, that were being carried out, but not documented, and created a new R-002-005 Quality calendar to prevent this from happen again. Additionally, we have registered according to the procedure GP-006 Non-conformities. Corrective and preventive actions one non-conformity related to the corresponding missing records of the TF with the corrective actions in place.

• Indicator 19, Number of technical assistances incidences registered. As we have already mentioned before at the feedback section of this document, during 2022 the number of technical assistances incidences registered increased compared to the previous year as expected (16 technical incidences in 2022 vs 7 in 2021), as the number of clients/users also increased (Indicator 9.R-002-002_Quality indicators: 14 new contracts signed with various users per contract).

Taking advantage of the new Quality Manager hiring, the T-002-003 Quality indicators record has been improved for the 2023 period with new indicators, improved ones and also adjustment of the targets to the current company context.

Other quality processes

• To ensure the proper monitoring of all the quality processes, we have created a quality calendar based on google calendar to ensure all the personnel have access to it, as it can be shown on their own calendars. This calendar shows all the periodic quality activities to be performed in the corresponding month and frequency established (R-002-005 Quality Calendar).
• The new Quality Manager is currently reviewing and updating all the documents and records of our QMS. She created a new version of the T-001-001 Control Documents and records and release the corresponding record last January 18 (R-001-001 Control Documents and records_2023_001), with the updates performed during the end of 2022 and first weeks of 2023. The new record contains different lists for the different kind of documents that we have along the QMS: Quality managemente and others, general and specific procedures, templates and data protection. When the TF for the new medical device regulation was finished it's index will be also included in this record.
• A new version of the Declaration of Conformity (R-001-002 2023_001 Manufacturer declaration of conformity) was approved with the updated social site address and a versions control section.
• As registered at the correponding R-001-004 Backup integrity verification, QMS and DHF backups integrity was properly checked and validated according to our procedures.
• The Quality Manager created a new record to control the external documents (R-001-005 List of external documents_2023_001)
• HR procedure: GP-005 HR and training procedure was updated including onboarding and offboarding procedures. In addition, templates codes were updated and included at the T-001-001 Control Documents and records to ensure their proper follow up when performing the corresponding activities. Currently we are planning to move all the registers required along the QMS for the HR procedures to our HR tool (Factorial), as the Job Descriptions and trainings records.
• As registered at the R-010-001 Suppliers evaluation 22_001, suppliers evaluation was carried out for the 2022 period performance with satisfactory results for all of our current suppliers.
• We also performed the infrastructure review (R-018-001 Infrastructure list and control plan 22_001) with satisfactory results.
• Regarding data protection, during August 2022 our DPO (Data Protection Officer) provided us with all the required documents (see DP-Annual certificate 2022) to comply with the data protection regulatory requirements, and we work with them in a daily basis (or when required) to ensure we are compling with them. In addition, during January 2023 we have updated the procedure DP-003 Security violations and we have included periodic security activities to ensure the protection of company equipment and data from cybersecurity vulnerabilities.
• AppFire, Google Workspace and Altassian softwares were properly validated according to our GP-019 Software validation procedure.

Monitoring and measurement of the product

We establish product verifications throughout the design and development process according to GP-012 Design and development, to comply with the Essential requirements (GSPR).

As we have mentioned in the previous section we have a system in place to monitor the processes and product performance that is described at the GP-002 Quality planning. R-002-003_Quality indicators_2022_001 shows that the product has properly operated during this period, as the quality control results has been satisfactory (Indicator 16), software lastest version has been 100% accesible to the users (Indicator 17), it has never been disabled (Indicator 20) and the technical assistance incidences were related to the initial usage of the product (see previous feedback section) and all of them quickly solved.

There have been no customer complaints, nor have incidents or adverse effects been detected as a result of the actions of the PMS Plan, during 2022 (Indicators 22 and 23).

We are also in the process of adapting our PMCF and CEP to improve the product follow up, and compiling all the information and data resulting from these activities to perform the corresponding reports and study the results to improve the product performance.

Non-conformities. Corrective and preventive actions (NC & CAPAs)

Number of NC & CAPAs

During this period we have registered 46 NC & CAPAs.The vast majority of them come from the different audits performed, not only the external ones as vendor, but also the internal audit.

NC & CAPAs area affected

As we have previously described at the audits section, and it is shown in the following graph, during the audits various non-conformities related to Human Resources procedures that we had not documented in our QMS were detected, and others that were related to procedures not registered according to our QMS.

A new Quality Manager was hired at the end of 2022 to improve the QMS management and all the procedures related to it and to the manufacturing process. She has already implemented a R-002-005 Quality calendar that contains all the events that need to be perform periodically to ensure we comply not only with the regulatory requirements, but also with our own procedures.

Additionally, we are currently working on the HR area to improve not only the area management, but also the tool in use (Factorial).

NC status

In the following graphs it is shown that almost a 75% of the NC & CAPAs are completely solved, and just less than 20% are still pending to establish the corrective and/or preventive actions. In addition, most of them are solved within the first month of reception (see barr graph) and only 2 of them require longer periods than 60 days due to their criticism and characteristics.

We expected to decrease the time the NC & CAPAs require to be completely solved with the new Quality Manager follow up.

Follow-up actions from previous management reviews

In the previous Quality Management Annual review we concluded that the QMS was satisfactory, at the expense of being able to guarantee these results with the first internal audit. As we have previously described, the grade of conformity of our QMS after the internal audit was satisfactory and the auditor indicated that we comply with the requirements established in the ISO 13485 standard.

Regarding the necessary changes to respond to applicable regulatory requirements, we detected we needed to adopt the following common provisions:

• New requirements according to MedDev 2.12.1 (Surveillance Reports), ie maximum duration to report 15 days

  • We have included this requirement at the GP-004 Surveillance System

• New requirements vs. MedDev 2.12-2 (Post-Market Clinical Follow-up), ie more frequent updates,

  • Yearly review (unless necessary shorter periods) frequency is included at the corresponding product T-007-002 Post-Market clinical follow-up (PMCF) plan

• Process/Procedures for communication with the Commission/Member States to obtain SRNs,

  • We have obtained our SRN number during this period (Actor ID/SRN:ES-MF-000025345)

• Registry EUDAMED of Economic Operators (Article 31),

  • We performed our registration as Economic Operator (Manufacturer) at EUDAMED during this period.

• Market Surveillance Systems (activities described in article 93),

  • During 2022 we have not received any request of the Competent Authorities to perform market control of our product, neither any inspection to control this activity.

• Serious Incident Reporting Systems, Field Safety Corrective Actions (Article 87) and Trends (Article 88),

  • The procedure to manage and report any of this activities is properly described at the GP-007 Post-market surveillance

• PMS Plan and Report Systems (Article 84, Article 85),

  • The procedure to manage and report any the Post-Market surveillance (PMS) is properly described at the GP-007 Post-market surveillance, and registered at their corresponding records based on the following templates: T-007-001 Post-Market Surveillance (PMS) Plan and T-007-004 PMS evaluation report, and also at the T-007-003 Periodic Safety Update Report (PSUR).

• Periodic Security Update Report Systems (Article 86) Class IIa or higher.

  • As we have described at the GP-007 Post-market surveillance, we will perform periodic (at least yearly) safety investigation activities and we will compile the results obtained at the T-007-003 Periodic Safety Update Report (PSUR).

Changes that could affect the QMS

In addtion to the modifications already described as a result of the audits performed during 2022, we are also adapting our QMS to the new 2017/745 Medical Device Regulation.

As it is described at the GP-001 Documents and records control, we are migrating our QMS documents and records to our own system (QMS.legit.health) to ensure a proper control of the documents.

During the revision of the HR procedures it could be possible that the GP-005 Human resources and training procedure and the corresponding records needed to be modified, or the records transferred to our HR tool in place (Factorial).

Recommendations for improvement

During this period we have studied all the recommendations received from the different sources (clients, audits, employees, consultants) and we have implemented all of the useful and relevant for us and for our clients.

The observations performed by the external audit were registered as NC & CAPAs and treated and solved as describe at the GP-006 Non-conformities. Corrective and preventive actions procedure.

During the internal audit, the auditor detailed on the corresponding audit report the following improvement opportunities:

• OPP01. It is strongly recommended to compile an unique index or list with all the documents archived at the QMS (SOPs, records, TF, etc.) containing information about their version, implementation date, and other relevant information useful for the company.

  • A new R-001-001 Control of Documents and records is created including these suggestions.

• OPP02. To include at the R-001-003 Backup copies control the different backups performed each time.

  • We will include on the record a description of the different backup copies performed.

• OPP03. It is recommended to increase the effort when performing the following annual management review including some relevant examples of the aspects reviewed as evidence, and higher degree of detail of the outputs, as the necessary resources and training plan for the next period.

  • This new Quality Management Annual Review is being performed with higher detail and deep to ensure all the QMS aspects are properly reviewed and documented.

• OPP04. It is recommended to archive every employee Job Description signed at their personnel file.

  • This recommendation will be implemented during the following months along with the HR procedure and tool improvement.

• OPP05.It is recommended to include the response time for the technical assistance activities

  • Response time will be included at the GP-017 Technical Assistance Service procedure

• OPP06. As the medical device traceability regarding clients is strongly registered, it is recommended to describe the procedure and include it at the QMS.

  • Customers medical device version traceability record will be created and the procedure SP-012 Software development management updated accordingly.

• OPP07. Implement signature procedures compliant with the 21 CFR part 11 at the new QMS and DHF

  • We are currently studing the different choices to comply with this requirement to implement the best suited for us.

Additionally, the new Quality Manager hired at the end of the year suggested other improvements already in place (some included as findings from the internal audit) as:

• QMS folders new agile structure
• External documents folder organization and registration (T-001-005 List of external documents)
• HR tool described at the procedures
• HR records organization improved
• Technical File independent index preparation

New or revised applicable regulatory requirements

Analysing the external documentation that applies to the product developed, and considering that the medical device currently on the market, LEGIT HEALTH is classified as CLASS I according to the previous European legislation for medical devices, the MDD 93/42 directive. CEE, being a legacy medical device, the transitory provisions regulated in article 120 of the MDR 2017/745 apply to it, as well as the different MDCG guides that apply to it.

The new proposal for a new Regulation to amend Regulation (EU) 2017/745 one (see table below, row 2) suggests a new deadline to complete the transition to this Regulation. As our product is Class II under the MDR 2017/745, our new due date would be December 2028, if this proposal is finally adopted.

Additionally, as we are planning to sell our product in UK, we have reviewed the regulatory requirements that rules there. Devices in the UK are regulated under the Medical Devices Regulations 2002 (see table below) which, prior to the end of the transition period for the 2017/745 MDR, gave effect in UK law to the Directive 93/42/EEC on medical devices (EU MDD). This means that the Great Britain route to market and UKCA marking requirements are based on the requirements derived from the above EU legislation. It is expected a new UK regulation by June 2023. Then we will carefully review it to adapt our system to the new requirements.

Regulation	Year
Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC ( 1 )	2017 Apply from may 2021
Proposal for a Regulation of the European Parliament and of the Council o 6 January 2023 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices	2023
MDCG 2020-15 MDCG Position Paper on the use of the EUDAMED actor registration module and of the Single Registration Number (SRN) in the Member States	2020
MDCG 2018-1 Rev. 4 Guidance on basic UDI-DI and changes to UDI-DI	2021
MDCG 2019-11 Qualification and classification of software - Regulation (EU) 2017/745 and Regulation (EU) 2017/746	2019
MDCG 2019-6 Rev.3 Questions and answers: Requirements relating to notified bodies	2021
MDCG 2020-5 Guidance on clinical evaluation – Equivalence	2020
MDCG 2020-6 Guidance on sufficient clinical evidence for legacy devices	2020
MDCG 2020-7 Guidance on PMCF plan template	2020
MDCG 2020-8 Guidance on PMCF evaluation report template	2020
MDCG 2020-3 Guidance on significant changes regarding the transitional provision under Article 120 of the MDR with regard to devices covered by certificates according to MDD or AIMDD	2020
MDCG 2021-25 Application f MDR requirements to "legacy devices" and to devices placed on the market prior to 26 May 2021 in accordance with Directives 90/385/EEC or 93/42/EEC	2021
MDCG 2022-21 Guidance on Periodic Safety Update Report (PSUR) according to Regulation (EU) 2017/745	2022
MDCG 2023-3 Questions and answers on vigilance terms and concepts as outlined in the Regulation (EU) 2017/745 on medical devices	2023
Medical Devices Regulations 2002. UK Statutory Instruments. No. 618	2002

Other new useful standards reviewed

• ISO/IEC 27001:2022 Information security, cybersecurity and privacy protection — Information security management systems — Requirements

  As it was already planned, when we finish the transition to the new 2017/745 MDR and we obtain the ISO 13485, we will complete adapting the QMS to this standard.

• ISO/IEC 23894:2023 Information technology — Artificial intelligence — Guidance on risk management

  This standard will be reviewed to improve our current risk management procedure.

Outputs

Necessary improvements to maintain the suitability, adequacy and effectiveness of the QMS and its processes

According to the entries received during the analysed period during the last two audits (one as vendor and the internal audit), and the favourable results of customer feedback and post market actions, we can consider that the performance of our QMS is satisfactory. However, we are highly compromised with the continous improvement as we have established in our Annex 1 Quality policy as one of our quality values, so that to achieve this improvement during this year we have planned to

• Complete the transition to the QMS.legit.health (Objective 3).

• Perform HR procedure improvements:

  • To adapt our HR tool in place (Factorial) to the HR management and records registration
  • JDs signature

• Implement signature procedures compliant with the 21 CFR part 11 at the new QMS and DHF

Product improvement in relation to customer requirements

The product design and development currently comply with all the customer requirements as we have previously described at the feedback section. Also, according to the Post-Market activities, it is evident that both the validation of the design and the risk management carried out during the design phase is adequate and the post-market results are satisfactory.

Additionally, to improve customer experience and satisfaction we are going to perform the following activities:

• IFU improvement including employees and clients feedback. We will include at the IFU a new section with more detailed instructions on how to take the pictures to upload to the software.
• IFU link included in the software
• To include a new functionality at the medical device that allows to upload more than one image and use all of them with the algorithm to obtain an improved result than if using just one.

Necessary changes to respond to new or revised applicable regulatory requirements

In accordance with the provisions of MDR 2017/745, common provisions must be adopted for products certified under MDD 93/42. During the last period we covered most of the new required provisions. We still need:

• To complete the Periodic Security Update Report Systems (Article 86) for Class IIa medical devices.
• To include the UDI-DI basic at the Technical File documents and to include the UDI-DI to the software labelling.

Additionally, to sell our product on the UK market, we need to register our medical device at the Medicines and Healthcare products Regulatory Agency (MHRA), responsible for regulating the UK medical devices market.

Necessary updates to Risk Management record

No necessary changes to the registry have been detected, except for those that may arise from the periodic review of the registry.

Necessary updates to Clinical Evaluation

In addition to the established periodic clinical evaluation activities compiled at the T-007-002 PMCF plan, Clinical evaluation will be updated with the clinical information being compiled at the moment:

• New papers published during the last year or being published during the following months.
• Clinical trials being performed, that we expected to finish during the following months.

Necessary resources

Regarding the (EU) 2017/745 MDR:

• To select and sign a contract with a notified body for the ISO 13485 and product CE marking.
• To contract at least one Dermatologist to review and validate the Clinical Evaluation being performed.

Regarding the UK market:

• To appoint a single UK Responsible Person for our device, who will act on our behalf to carry out specified tasks, such as registration.

Company strategy:

• To select and hire a Sales Development Representative
• To determine if new Factorial modules are required

Record signature meaning

• Author: JD-004 María Diez
• Review and approval: JD-001 Andy Aguilar