R-005-003 Training plan 2023_001
Training matrix
| JD-001 | JD-002 | JD-003 | JD-004 | JD-005 | JD-006 | JD-007 | JD-008 | JD-009 | JD-010 | JD-011 | |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Prevention of risk at work | Trainee | Trainee | Trainee | Trainee | Trainee | Trainee | Trainee | Trainee | Trainee | Trainee | Trainee |
| GDPR | Trainee | Trainee | 👩🏫 | Trainee | Trainee | Trainee | Trainee | Trainee | Trainee | Trainee | Trainee |
| Cybersecurity | Trainee | Trainee | 👩🏫 | Trainee | Trainee | Trainee | Trainee | Trainee | Trainee | Trainee | Trainee |
| Good Clinical Practice | Trainee | Trainee | |||||||||
| QMS | Trainee | Trainee | 👩🏫 | Trainee | Trainee | Trainee | Trainee | Trainee | Trainee | Trainee | Trainee |
| SP-012-001 | 👩🏫 | Trainee | Trainee |
👩🏫 Trainer
Training plan
| Date | Employee | Title of the training | Taught by | Planified on | Approved by JD-001 General manager? | Estimated Duration (h) | Training objective | Participant evaluation: Applicability | Participant evaluation: Materials | Participant evaluation: Organization | Participant evaluation: 👩🏫 | Average evaluation by the participant | Evaluation by the JD-001 General Manager | Comments |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 20210111 | Alfonso Medela | Prevention of risk at work | Prevenlabur | 20210108 | Yes | 2 | Prevent risk at work | 7 | 6 | 8 | 6 | 7 | 10 | |
| 20210111 | Gerardo Fernandez | Prevention of risk at work | Prevenlabur | 20210108 | Yes | 2 | Prevent risk at work | 6 | 7 | 5 | 9 | 7 | 10 | |
| 20210111 | Andy Aguilar | Prevention of risk at work | Prevenlabur | 20210108 | Yes | 2 | Prevent risk at work | 10 | 10 | 10 | 9 | 10 | 10 | |
| 20210111 | Cristian Sotos | Prevention of risk at work | Prevenlabur | 20210108 | Yes | 2 | Prevent risk at work | 8 | 8 | 9 | 8 | 8 | 10 | |
| 20210111 | Taig Mac Carthy | Prevention of risk at work | Prevenlabur | 20210108 | Yes | 2 | Prevent risk at work | 9 | 7 | 7 | 9 | 8 | 10 | |
| 20210111 | Ignacio Hernandez | Prevention of risk at work | Prevenlabur | 20210108 | Yes | 2 | Prevent risk at work | 8 | 7 | 7 | 8 | 7 | 10 | |
| 20210214 | Alfonso Medela | Data privacy | Taig Mac Carthy | 20210210 | Yes | 2 | Understand the GDPR | 9 | 7 | 7 | 10 | 8 | 9 | |
| 20210215 | Gerardo Fernandez | Data privacy | Taig Mac Carthy | 20210210 | Yes | 2 | Understand the GDPR | 7 | 7 | 7 | 9 | 8 | 9 | |
| 20210215 | Andy Aguilar | Data privacy | Taig Mac Carthy | 20210210 | Yes | 2 | Understand the GDPR | 9 | 7 | 8 | 9 | 9 | 9 | |
| 20210216 | Cristian Sotos | Data privacy | Taig Mac Carthy | 20210210 | Yes | 2 | Understand the GDPR | 9 | 8 | 8 | 9 | 8 | 9 | |
| 20210616 | Nerea Ruiz de Gauna | Prevention of risk at work | Prevenlabur | 20210612 | Yes | 2 | Prevent risk at work | 8 | 10 | 9 | 8 | 9 | 10 | |
| 20210616 | Sara Recalde | Prevention of risk at work | Prevenlabur | 20210612 | Yes | 2 | Prevent risk at work | 8 | 8 | 7 | 7 | 7 | 10 | |
| 20210617 | Rebecca Barrena | Prevention of risk at work | Prevenlabur | 20210612 | Yes | 2 | Prevent risk at work | 10 | 9 | 8 | 8 | 8 | 10 | |
| 20210922 | Nerea Ruiz de Gauna | Data privacy | Taig Mac Carthy | 20210921 | Yes | 2 | Understand the GDPR | 8 | 10 | 10 | 9 | 9 | 9 | |
| 20210922 | Sara Recalde | Data privacy | Taig Mac Carthy | 20210921 | Yes | 2 | Understand the GDPR | 9 | 8 | 9 | 7 | 9 | 9 | |
| 20210922 | Rebecca Barrena | Data privacy | Taig Mac Carthy | 20210921 | Yes | 2 | Understand the GDPR | 10 | 9 | 10 | 8 | 8 | 9 | |
| 20220411 | Alfonso Medela | Good clinical practise | Alfonso Medela | 20220411 | Yes | 2 | Understand how to correctly execute clinical trials | 10 | 10 | 10 | 10 | 10 | 8 | |
| 20220411 | Taig Mac Carthy | Good clinical practise | Taig Mac Carthy | 20220411 | Yes | 2 | Understand how to correctly execute clinical trials | 8 | 9 | 8 | 8 | 8 | 8 | |
| 20220526 | Ignacio Hernandez | Data privacy | Taig Mac Carthy | 20220523 | Yes | 2 | Understand the GDPR | 9 | 8 | 8 | 7 | 9 | 8 |
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 training | Evaluation by the participant | Evaluation by the JD-001 General Manager | Date |
|---|---|---|---|
| Prevention of risk at work | 10 | 10 | 20210108 |
| Data privacy | 9 | 9 | 20210210 |
| QMS | 9 | 9 | 20221027 |
| GDPR | 10 | 10 | 20221103 |
| Created by | Accepted by |
|---|---|
E-Signature (Appfire integration):  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): Andy Aguilar FAD4CB062963A6C8C6D735A23DD0EC6A Signer name: Andy Aguilar Signing time: Tue, 20 Dec 2022 12:52:31 GMT Reason: Approved |
| JD-003 Design & Development Manager | JD-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 training | Evaluation by the participant | Evaluation by the JD-001 General Manager | Date |
|---|---|---|---|
| Medical device technical manager | 9 | 9 | 20200626 |
| Prevention of risk at work | 7 | 10 | 20210108 |
| Data privacy | 8 | 9 | 20210210 |
| Good clinical practise | 10 | 8 | 20220411 |
| QMS | 9 | 9 | 20221027 |
| GDPR | 8 | 10 | 20221103 |
| Created by | Accepted by |
|---|---|
E-Signature (Appfire integration): Alfonso Medela B144B9CE0E9E0900E0097059D03070AC Signer name: Alfonso Medela Signing time: Tue, 20 Dec 2022 09:03:18 GMT Reason: Created | E-Signature (Appfire integration): 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 training | Evaluation by the participant | Evaluation by the JD-001 General Manager | Date |
|---|---|---|---|
| Strategic Management and Innovation Specialization | 8 | 10 | 20160416 |
| ISO 13485 | 8 | 10 | 20201003 |
| Quality Management Systems ISO 9001:2015 | 8 | 10 | 20201212 |
| Prevention of risk at work | 8 | 10 | 20210108 |
| Good Clinical Practice | 8 | 8 | 20220411 |
| Created by | Accepted by |
|---|---|
E-Signature (Appfire integration): Taig Mac Carthy 6F21166F168C6F79070E4B61A6ECE428 Signer name: Taig Mac Carthy Signing time: Sat, 24 Sep 2022 00:00:00 GMT Reason: Created | E-Signature (Appfire integration): Andy Aguilar 92D8162DF4A424FB2926AB5A75420880 Signer name: Andy Aguilar Signing time: Sat, 24 Sep 2022 00:00:00 GMT Reason: Approved |
| JD-003 Design & Development Manager | JD-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 training | Evaluation by the participant | Evaluation by the JD-001 General Manager | Date |
|---|---|---|---|
| Prevention of risk at work | 7 | 10 | 20210108 |
| Data privacy | 8 | 9 | 20210210 |
| QMS | 8 | 9 | 20221027 |
| GDPR | 9 | 10 | 20221103 |
| Created by | Accepted by |
|---|---|
E-Signature (Appfire integration): Gerardo Fernandez 40490376BFE7B7C9E4EBFD0A1088FCEE Signer name: Gerardo Fernandez Signing time: Tue, 20 Dec 2022 12:36:44 GMT Reason: Created | E-Signature (Appfire integration): Andy Aguilar AAB102100975C109853CAE3A511E0572 Signer name: Andy Aguilar Signing time: Tue, 20 Dec 2022 12:54:02 GMT Reason: Approved |
| JD-007 Technology Manager | JD-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 training | Evaluation by the participant | Evaluation by the JD-001 General Manager | Date |
|---|---|---|---|
| Prevention of risk at work | 8 | 10 | 20221117 |
| Data privacy | 8 | 9 | 20221117 |
| GDPR | 9 | 9 | 20221119 |
| QMS | 10 | 10 | 20221118 |
| The role of economic operators in relation to the requirements of regulation 2017/745. How to rely on ISO 13485 | 8 | 8 | 20230203 |
| What is UDI and how is it created? | 10 | 10 | 20230309 |
| Royal Decree 192:2023 regarding medical device news | 9 | 9 | 20230330 |
| Control status maintenance | 8 | 8 | 20230517 |
| Created by | Accepted by |
|---|---|
E-Signature (Appfire integration): María Diez AE81FF9FDB62F84EED663A41A92FA8A9 Signer name: María Diez Signing time: Fri, 19 May 2023 15:28:32 GMT Reason: Created | E-Signature (Appfire integration): 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 |
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 Design & Development Manager, JD-004 Quality Manager & PRRC
- Approver: JD-001 General Manager