R-TF-015-007 Delaration of interest Clinical evaluation team 2023_003
Declaration of interest
I, Taig Mac Carthy, hereby declare my interests, including financial and non-financial, in relation to the evaluation of Legit.Health Plus as part of the Clinical Evaluation Report (CER) for AI Labs Group S.L. This declaration is made in accordance with the regulatory requirements and internal policies of our organization.
- 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.
- Experience with the product/process/technology: Taig is a front-end developer, programmer, designer and serial entrepreneur with more than 9 years of experience. He has a broad professional experience and is noted for having co-founder of several startups. It is also worth mentioning that he has developed in the field of management and as a consultant. He has written two books on entrepreneurship and a book on viral marketing. He teaches workshops and training on entrepreneurship, marketing and advertising. His experience also includes more than 4 years of working with the product throughout its life cycle, as he is one of the co-funders of the company and he has participated in the product manufacturing since the begining.
I acknowledge and confirm the following:
- I am an employee of AI Labs Group S.L.
- I have direct financial interests or relationships, such as ownership of shares, patents, proprietary rights, or royalty agreements, related to Legit.Health Plus or its manufacturer that could influence my evaluation.
- I have not received any gifts, incentives, or contributions that may influence my judgment during the evaluation of the device.
- I understand that it is my responsibility to promptly disclose any potential conflict of interest that may arise during the course of the evaluation.
I acknowledge that the purpose of this declaration is to ensure transparency and the highest ethical standards in the evaluation of the device. By signing below, I confirm that I have disclosed all relevant interests to the best of my knowledge.
Record signature meaning
- Author: JD-004 María Diez
- Clinical evaluator approval: JD-003 Taig Mac Carthy
- General Manager approval: JD-001 Andy Aguilar