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      • Deprecated
        • JD-001 General Manager 2022_001
        • JD-002 Sales Manager 2022_001
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        • JD-004 Quality Manager and Person Responsible for Regulatory Compliance (PRRC) 2022_001
        • JD-005 Technical Manager & Person Responsible for Regulatory Compliance (PRRC) 2022_001
        • JD-006 HR Manager 2022_001
        • R-005-001 Training plan 2022_001
        • R-005-003 Training plan 2023_001
        • R-005-003 Training plan 2024_001
        • R-005-003 Training plan 2024
      • R-005-003 Training plan 2025
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  • R-005-003 Training plan 2023_001

R-005-003 Training plan 2023_001

Written byReviewed by

E-Signature (Appfire integration):

Signature logo

María Diez

75432E7837B188183A868C80FEDD60FE

Signer name: María Diez

Signing time: Mon, 30 Jan 2023 15:02:56 GMT

Reason: Creation of document

E-Signature (Appfire integration):

Signature logo

Alfonso Medela

EB1C522F57DF45A5FC177018B8DA8D59

Signer name: Alfonso Medela

Signing time: Tue, 31 Jan 2023 15:02:04 GMT

Reason: Reviewed

Quality manager (QM)Technical manager (PRRC)

Training matrix​

JD-001JD-002JD-003JD-004JD-005JD-006JD-007JD-008JD-009JD-010JD-011
Prevention of risk at workTraineeTraineeTraineeTraineeTraineeTraineeTraineeTraineeTraineeTraineeTrainee
GDPRTraineeTrainee👩‍🏫TraineeTraineeTraineeTraineeTraineeTraineeTraineeTrainee
CybersecurityTraineeTrainee👩‍🏫TraineeTraineeTraineeTraineeTraineeTraineeTraineeTrainee
Good Clinical PracticeTraineeTrainee
QMSTraineeTrainee👩‍🏫TraineeTraineeTraineeTraineeTraineeTraineeTraineeTrainee
SP-012-001👩‍🏫TraineeTrainee
info

👩‍🏫 Trainer

Training plan​

DateEmployeeTitle of the trainingTaught byPlanified onApproved by JD-001 General manager?Estimated Duration (h)Training objectiveParticipant evaluation: ApplicabilityParticipant evaluation: MaterialsParticipant evaluation: OrganizationParticipant evaluation: 👩‍🏫Average evaluation by the participantEvaluation by the JD-001 General ManagerComments
20210111Alfonso MedelaPrevention of risk at workPrevenlabur20210108Yes2Prevent risk at work7686710
20210111Gerardo FernandezPrevention of risk at workPrevenlabur20210108Yes2Prevent risk at work6759710
20210111Andy AguilarPrevention of risk at workPrevenlabur20210108Yes2Prevent risk at work10101091010
20210111Cristian SotosPrevention of risk at workPrevenlabur20210108Yes2Prevent risk at work8898810
20210111Taig Mac CarthyPrevention of risk at workPrevenlabur20210108Yes2Prevent risk at work9779810
20210111Ignacio HernandezPrevention of risk at workPrevenlabur20210108Yes2Prevent risk at work8778710
20210214Alfonso MedelaData privacyTaig Mac Carthy20210210Yes2Understand the GDPR9771089
20210215Gerardo FernandezData privacyTaig Mac Carthy20210210Yes2Understand the GDPR777989
20210215Andy AguilarData privacyTaig Mac Carthy20210210Yes2Understand the GDPR978999
20210216Cristian SotosData privacyTaig Mac Carthy20210210Yes2Understand the GDPR988989
20210616Nerea Ruiz de GaunaPrevention of risk at workPrevenlabur20210612Yes2Prevent risk at work81098910
20210616Sara RecaldePrevention of risk at workPrevenlabur20210612Yes2Prevent risk at work8877710
20210617Rebecca BarrenaPrevention of risk at workPrevenlabur20210612Yes2Prevent risk at work10988810
20210922Nerea Ruiz de GaunaData privacyTaig Mac Carthy20210921Yes2Understand the GDPR81010999
20210922Sara RecaldeData privacyTaig Mac Carthy20210921Yes2Understand the GDPR989799
20210922Rebecca BarrenaData privacyTaig Mac Carthy20210921Yes2Understand the GDPR10910889
20220411Alfonso MedelaGood clinical practiseAlfonso Medela20220411Yes2Understand how to correctly execute clinical trials10101010108
20220411Taig Mac CarthyGood clinical practiseTaig Mac Carthy20220411Yes2Understand how to correctly execute clinical trials898888
20220526Ignacio HernandezData privacyTaig Mac Carthy20220523Yes2Understand the GDPR988798

Andy Aguilar​

Education​

Andy has a degree in business administration and business strategies from Tecnologico de Monterrey and has completed two internships: one in innovation and entrepreneurship at the University of Mississippi and another in business administration and marketing at the University of the Basque Country.

Professional experience​

Her professional experience includes more than 4 years in sales and more than 2 years as e-commerce manager in two international B2C companies.

Training actions​

Title of the trainingEvaluation by the participantEvaluation by the JD-001 General ManagerDate
Prevention of risk at work101020210108
Data privacy9920210210
QMS9920221027
GDPR101020221103
Created byAccepted by

E-Signature (Appfire integration):

Signature logo

Taig Mac Carthy

8CB41EE11A7DAFF88959070EF96132E7

Signer name: Taig Mac Carthy

Signing time: Tue, 20 Dec 2022 09:02:31 GMT

Reason: Created

E-Signature (Appfire integration):

Signature logo

Andy Aguilar

FAD4CB062963A6C8C6D735A23DD0EC6A

Signer name: Andy Aguilar

Signing time: Tue, 20 Dec 2022 12:52:31 GMT

Reason: Approved

JD-003 Design & Development ManagerJD-001 General Manager

Alfonso Medela​

Education​

Alfonso holds a degree in physics from the University of the Basque Country. In addition, he completed his training with a MSc. in Physics at the University of Groningen and a MSc. in Big Data and intelligence. University of Groningen and another Master in Big Data and Business Intelligence at the at the University of Deusto.

Professional experience​

Alfonso is an expert in computer vision, machine learning and artificial intelligence with more than 7 years of experience in the development of projects with medical approaches. His experience includes his time at Tecnalia Research & Innovation where he worked as a data scientist focused on Deep Learning algorithms in the area of Computer Vision.

He has written 7 papers on machine learning and image recognition, he also teaches workshops and courses on machine learning and deep learning. At the European level, he is one of the few experts on the few-shot learning methodology in the field of artificial intelligence.

Training actions​

Title of the trainingEvaluation by the participantEvaluation by the JD-001 General ManagerDate
Medical device technical manager9920200626
Prevention of risk at work71020210108
Data privacy8920210210
Good clinical practise10820220411
QMS9920221027
GDPR81020221103
Created byAccepted by

E-Signature (Appfire integration):

Signature logo

Alfonso Medela

B144B9CE0E9E0900E0097059D03070AC

Signer name: Alfonso Medela

Signing time: Tue, 20 Dec 2022 09:03:18 GMT

Reason: Created

E-Signature (Appfire integration):

Signature logo

Andy Aguilar

0DC6954A2C989C5101521F97390A7B1A

Signer name: Andy Aguilar

Signing time: Tue, 20 Dec 2022 12:53:13 GMT

Reason: Approved

JD-005 Technical Manager & Person Responsible for Regulatory Compliance (PRRC)JD-001 General Manager

Taig Mac Carthy​

Education​

with a specialization in Strategic Management and Innovation from Copenhagen Business School, he has a foundational understanding of business practices essential in product development. His knowledge in quality management systems is well-established, having completed ISO 13485, ISO 9001:2015, and ISO 27001 Lead Auditor certifications from Bureau Veritas Group. These certifications underscore his ability to maintain high-quality standards in device manufacturing. Additionally, his training in ICH Good Clinical Practice and as an Equal Opportunity Agent, alongside courses in Python, Data Science, and Graphic Design, provide a diverse skill set applicable to his current role. His academic journey also includes a degree from the University of the Basque Country.

Professional experience​

solid background in both the medical and entrepreneurial fields. He has contributed to four scientific publications in computer vision applied to medicine, showcasing his expertise in areas directly relevant to medical device development. His involvement from the inception of the company, given his position as co-founder, has afforded him comprehensive knowledge of the device's development journey. His six years as a front-end software developer and the founding of three companies demonstrate his technical skills and entrepreneurial mindset. Additionally, his authorship of two business management books indicates his grasp on business operations, all of which collectively support his capacity to lead in design and development.

Training actions​

Title of the trainingEvaluation by the participantEvaluation by the JD-001 General ManagerDate
Strategic Management and Innovation Specialization81020160416
ISO 1348581020201003
Quality Management Systems ISO 9001:201581020201212
Prevention of risk at work81020210108
Good Clinical Practice8820220411
Created byAccepted by

E-Signature (Appfire integration):

Signature logo

Taig Mac Carthy

446B9ECEF0B3DBCFAA27A2618D6C4DD8

Signer name: Taig Mac Carthy

Signing time: Sun, 11 Sep 2022 14:01:42 GMT

Reason: Created

E-Signature (Appfire integration):

Signature logo

Andy Aguilar

077475E323E2B048966060431C67F749

Signer name: Andy Aguilar

Signing time: Sun, 11 Sep 2022 14:01:42 GMT

Reason: Approved

JD-003 Design & Development ManagerJD-001 General Manager

Gerardo Fernandez​

Education​

Gerardo studied mathematics and computer science at the Autonomous University of Madrid and has been learning programming in a self-taught way since then.

Professional experience​

Gerardo started his professional career in the development of webs and mobile applications. In 2014 he started working under the name of his own brand called Latte and Code. Two years later Promotive Group, one of the companies he worked with on a regular basis offered him to be their CTO in order to develop a CRM for the company. After closing the stage in Grupo Promotive he went back to freelance development to seek new challenges. He even opened a Youtube channel where he can continue to enjoy one of his vocations: teaching others. He is currently CTO of Legit.Health.

Training actions​

Title of the trainingEvaluation by the participantEvaluation by the JD-001 General ManagerDate
Prevention of risk at work71020210108
Data privacy8920210210
QMS8920221027
GDPR91020221103
Created byAccepted by

E-Signature (Appfire integration):

Signature logo

Gerardo Fernandez

40490376BFE7B7C9E4EBFD0A1088FCEE

Signer name: Gerardo Fernandez

Signing time: Tue, 20 Dec 2022 12:36:44 GMT

Reason: Created

E-Signature (Appfire integration):

Signature logo

Andy Aguilar

AAB102100975C109853CAE3A511E0572

Signer name: Andy Aguilar

Signing time: Tue, 20 Dec 2022 12:54:02 GMT

Reason: Approved

JD-007 Technology ManagerJD-001 General Manager

María Diez​

Education​

María studied Biology at the Complutense University of Madrid. In addition, she holds a PhD on Biochemistry and Molecular Biology by the same University.

Professional experience​

With more than 6 years on Quality and Regulatory experience, María started developing her abilities implementing a Quality Management system based on ISO 15189, CLIA and Spanish sanitary regulations (specific for medical laboratories), clinical studies and in vitro Software as medical device. On her last work experience she developed and integrated QMS combining the ISO 9001, ISO 13485, ISO 15189 and ISO 27001 regulations with the requirements established at the 2017/746 European in vitro medical device regulations, again for a Software as medical device.

Training actions​

Title of the trainingEvaluation by the participantEvaluation by the JD-001 General ManagerDate
Prevention of risk at work81020221117
Data privacy8920221117
GDPR9920221119
QMS101020221118
The role of economic operators in relation to the requirements of regulation 2017/745. How to rely on ISO 134858820230203
What is UDI and how is it created?101020230309
Royal Decree 192:2023 regarding medical device news9920230330
Control status maintenance8820230517
Created byAccepted by

E-Signature (Appfire integration):

Signature logo

María Diez

AE81FF9FDB62F84EED663A41A92FA8A9

Signer name: María Diez

Signing time: Fri, 19 May 2023 15:28:32 GMT

Reason: Created

E-Signature (Appfire integration):

Signature logo

Andy Aguilar

CBA6268F110D4ACFD6C4CA6E6F3B73D2

Signer name: Andy Aguilar

Signing time: Tue, 23 May 2023 08:18:32 GMT

Reason: Approved

JD-004 Quality Manager & Person Responsible for Regulatory Compliance (PRRC)JD-001 General Manager
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R-005-001 Training plan 2022_001
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R-005-003 Training plan 2024_001
  • Training matrix
  • Training plan
  • Andy Aguilar
    • Education
    • Professional experience
    • Training actions
  • Alfonso Medela
    • Education
    • Professional experience
    • Training actions
  • Taig Mac Carthy
    • Education
    • Professional experience
    • Training actions
  • Gerardo Fernandez
    • Education
    • Professional experience
    • Training actions
  • María Diez
    • Education
    • Professional experience
    • Training actions
All the information contained in this QMS is confidential. The recipient agrees not to transmit or reproduce the information, neither by himself nor by third parties, through whichever means, without obtaining the prior written permission of Legit.Health (AI LABS GROUP S.L.)