Team


MEDTECH CRO STRATEGISTS

MDT is a world-class team of industry professionals with extensive expertise in bringing innovative medical devices and in-vitro diagnostics technologies to market and keeping existing devices in compliance. Ready to work on your medical device registration and approval, QMS compliance, regulatory affairs, and clinical affairs.

Their MedTech Experts are pleased to support your project plan and explore a partnership with your company’s regulatory, quality, and clinical affairs departments to support them to reach the targets while saving time and resources.

 

INTERNATIONAL SUPPORT

MDT team is proficient at providing international support:

  • in 6 international languages (English, French, Italian, Spanish, Portuguese, and Chinese).
  • for Medical Devices (MD) and Medical Device Software (MDSW/SaMD).
  • for In-Vitro Diagnostics (IVD), In-house testing (LTD), and In Vitro Diagnostics Software (IVDSW/SaIVD).
  • with MD/IVD consultants, experts, and clinical researchers that hold advanced degrees in the healthcare sciences such as PhD., Clinical Research MSc, Biomedical Engineering and Mathematics.
  •  with international standards such as ISO 13485, ISO 14155, ISO 14971, ISO 20189, ISO 15189, ISO 17025, ISO 62304, and good clinical practice (GCP) and good laboratory practice (GLP) can be met with a well-trained team in medical technologies.
  • with experts in the European Regulations, EU MDR 2017/745 and EU IVDR 2017/746.

DAVID TOMÉ, MSc. picture profile

DAVID TOMÉ, MSc.

CLINICAL RESEARCH AND REGULATORY EXPERT

David is in charge of the Project Operations.

David Tomé completed his MSc in Environmental Biology and has more than 15 years of experience working internationally with the MedTech Industry, Research and Development departments, scientific data support initiatives, communication with evidence-based medicine, and healthcare stakeholders.

David has spent his career managing operations supported by science, notably in the clinical and regulatory sectors with Medical Devices and In-Vitro Diagnostic Devices. He has built a methodical and ethical approach to organizing regulatory, clinical, and technical teams in a win-win partnership with manufacturers, key purchasers, principal investigators, engineers, clinical sites, opinion leaders, and marketers.

During this time, David has worked on more than 100 MedTech product initiatives that have met and, in some cases, exceeded their initial goals. He is currently a MedTech guest speaker in academic settings and healthcare business institutions.


HUGO LEIS, PhD. picture profile

HUGO LEIS, PhD.

REGULATORY AND CLINICAL QUALITY EXPERT

Hugo is a Clinical Quality and MedTech Expert for MedTech-IVD projects.

Hugo provides clinical quality assurance and clinical evaluations for medical technology and in vitro diagnostics (MedTech-IVD) development projects.

He is a veterinarian with a doctorate in molecular biology and genetics. At prestigious research institutions (CSIC, IVIA, CIEMAT, CIPF), and manufacturers, he has collaborated on basic and clinical research projects involving multidisciplinary teams studying uncommon illnesses and genetic diagnostics. He has extensive experience in the fields of analytical method development, the management of diagnostic laboratories and IVD manufacturers, and the facilitation of the idea-to-market phase of a wide range of breakthrough innovations, where he has taken the helm in terms of design, development, and regulatory operations.

Through his advanced studies in regulatory and quality management, he has gained a holistic perspective on the biotechnology process and ecosystem, including the use of software as a medical device. Furthermore, he has substantial expertise in conducting both internal and external audits for Notified Bodies and Accreditation Bodies.

Hugo is also a Guest Speaker in the academic field and in healthcare institutions.


YAIZA BENITO, MSc. picture profile

YAIZA BENITO, MSc.

CLINICAL RESEARCH AND REGULATORY EXPERT

Yaiza is a Clinical Research and Regulatory Expert for MedTech-IVD projects.

She is a Biomedical Engineer specializing in bioengineering, software, gynecology, and clinical research affairs. Yaiza has acquired knowledge about biomechanics, clinical data analysis, and management and policy aspects of technology in healthcare in international contexts. Yaiza has completed an MSc in Technological Innovation in Health, boosting her technical skills with a comprehensive vision of the dynamic MedTech industry and startup ecosystem.

Yaiza has been part of different national and European projects related to a broad spectrum of biomedical products, including medical software, exoskeletons, remote monitoring implantable sensors, and high-risk medical devices.

Yaiza brings the MedTech start-up manufacturer and the hospital environment experience where she has worked as CRA and the adaptability to multidisciplinary teams and tasks acquired at scientific centers (CSIC), where she has collaborated as a researcher on neurorehabilitation.


MIGUEL HUERTA, MSc. picture profile

MIGUEL HUERTA, MSc.

CLINICAL RESEARCH AND REGULATORY EXPERT

Miguel is a Clinical and Regulatory Expert for MedTech-IVD projects.

He is a Biomaterials Engineering specialist with an MSc. in Biomedical Engineering. With four years of experience managing projects in biomedicine, Miguel has expertise in combination products such as drug delivery systems and biomaterial-cell interactions. He has participated in various research projects involving several scientific centers and hospitals to develop medical device products such as lotion, aerosol sprays, or materials coatings. Furthermore, he has experience performing pre-clinical evaluations of novel products for oncologic immunotherapy.

Miguel’s experience in national and international working environments in the development of new IVDs and medical devices.


IRENE AYERRA, MSc. picture profile

IRENE AYERRA, MSc.

BIOSTATISTICAL AND DATA SCIENCE EXPERT

Irene is an expert in Biostatistics and Data Science for MedTech-IVD related initiatives.

She is a Mathematician with a MSc. in Mathematical Modeling and Research, Statistics and Computer Science. Irene has developed her expertise in eHealth and mathematical algorithms as founder and CEO of an innovative startup dedicated to Transfusion Medicine. Irene can perform high-quality work in clinical research, Data Management, Data Analysis and Biostatistics for Start-ups, research centers, and medical device innovations due to her background researching, optimizing and improving processes in blood establishments.

Irene contributes her expertise in creative development and her adaptation to interdisciplinary teams to a MedTech startup ecosystem.


HUIWEN XU, Ph.D. picture profile

HUIWEN XU, Ph.D.

CLINICAL RESEARCH AND REGULATORY EXPERT

Huiwen is a Clinical and Regulatory Expert for MedTech-IVD projects.

She has a doctorate in biomedicine, specializing in medical devices and microbiota data analysis. She has collaborated on projects related to the effect of different variables such as cold, meal, and exercise on human metabolism, measuring with DXA (dual-energy x-ray absorptiometry), indirect calorimetric, and temperature sensors. In addition, she has experience performing  proof-of-concept, preclinical and clinical studies with medical device prototypes.

Furthermore, she has got experience working with international groups Magdeburg (Germany) and Granada (Spain), where she has acquired knowledge about the extraction and analysis of human microbiota.

Huiwen is also a university guest speaker in biochemistry at the University of Granada.





Fondo Social Europeo dentro de la Ayuda a la Recuperación para la Cohesión y los Territorios de Europa (REACT-UE)

MED IVD HEALTHTECH S.L ha sido beneficiaria de la subvención de contratos de trabajo de la Comunidad de Madrid, cofinanciado por el Fondo Social Europeo dentro de la Ayuda a la Recuperación para la Cohesión y los Territorios de Europa (REACT-UE), a través del Programa Operativo Regional FSE, en el marco del Programa Impulso a la Contratación Estable de Jóvenes para la Recuperación Económica, gestionado por la Dirección General del Servicio Público de empleo de la Consejería de Economía, hacienda y empleo de la Comunidad de Madrid.


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MDT| MedTech-IVD CRO

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