Our team

Maria Nyåkern is the President and CEO, leading the company to align the organization to its expansion in the medical device B2B sector. She is the Principal Advisor and Clinical and Regulatory Subject Matter Expert.

Dr. Nyåkern founded AKRN Scientific Consulting in 2017 after working nearly 15 years in the regulatory and clinical development of medical device technology. 

Maria Nyåkern is a Doctor of Cell Biology at Stockholm University, Sweden (2003), and has completed a Postdoctoral Fellowship at the University of Bologna, Italy (2006). Maria is fluent in English, Spanish, Italian, French, and Swedish.

Maria and the AKRN team provides Expert Consulting in:

• Clinical Evaluations according to MEDDEV 2.7/1 Rev 4 Guideline
• Clinical Investigations according to ISO 14155:2020 GCP Standard 
• Compliance to EU MDR 2017/745 and EU IVDR 2017/746
• Regulatory / Medical document preparation (CER, PER, PMS, SSCP, PMCF, and more)
• Guidance on QMS 13485:2016 implementation 

Diana Posa Podean is the Associate Director of Clinical Affairs and is responsible for the design and successful execution of clinical investigations that demonstrate product safety and performance, and ensuring that investigations are conducted in full compliance to GCP and ISO 14155 and all other applicable regulatory requirements. She manages the staff of department managers, study managers, and CRAs, as well as external vendors such as CROs, Core Labs, Medical Monitors, Data Management, and Biostatistics. 

Diana Posa Podean is a Doctor of Pharmacy (Pharm.D) who graduated in 2016 and she has a Master of Molecular Biology from Alcalá University (2017). Diana is fluent in Spanish, English, and Rumanian.

Ariadna Navarro is the Associate Director of Regulatory Affairs and is an experienced clinical research and regulatory professional with excellent scientific expertise as well as strong project management and leadership capabilities. She has expert knowledge in European Device and IVD Regulations and the GCP standards for clinical investigations of medical devices and in-vitro diagnostics (ISO 14155.2020 and ISO 20916:2019). Dr. Navarro is supporting global manufacturers in MDD to MDR and IVDD to IVDR transitions and the development of Technical Documentation for Medical Devices and in-vitro Diagnostics. She is also leading the training of our employees to ensure compliance with EU Medical Device and IVD Regulations. Ariadna Navarro is a Biotechnologist (BSc) who graduated in 2012 from the Autonomous University of Barcelona. She has a Master of Genetics of Human Disease (UCL, 2014) and a Ph.D. in Cardiovascular Sciences from University College London (UCL, 2019), and she is fluent in Spanish, English, and Catalan.

Raquel Cordeiro is a Clinical Affairs and Operations Manager leading European clinical study projects. She also performs clinical trial site management and monitoring in compliance with ISO 14155:2020.

Dr. Cordeiro has broad international scientific experience and excellent project management skills.

Raquel obtained her Ph.D. in Biotechnology with a Marie-Curie Fellowship at the Ruhr-Universittät Bochum in Germany. Part of her Ph.D. was also done at SARomics Biostructures AB in Lund, Sweden, and EntreChem in Oviedo, Spain. She finished her academic research with a postdoctoral fellowship in Crystallography and Protein Engineering at the Spanish National Cancer Research Centre in Madrid (Spain).

Raquel Cordeiro has a degree in Applied Chemistry (BSc) and a master’s degree in Biochemistry (MSc) from the Faculdade de Ciencia e Tecnologia de Universidade Nova de Lisboa, Portugal.

She speaks Portuguese (mother tongue), English, Spanish, and German.

Ruben Ruiz is a Clinical Affairs Manager with excellent scientific expertise as well as strong leadership capabilities. Mr. Ruiz is an expert in Portuguese EC/CA Submissions (InfarMed and CEIC). He also performs clinical trial site management and monitoring in compliance with ISO 14155 GCP Standard and MDD to MDR Gap Analysis according to EU MDR 2017/745.

Ruben has a strong background in biomedical research and prior to joining our company, he worked as a Researcher at the Center for Neurogenomics and Cognitive Research (the Netherlands) studying the influence of insulin/IGF-1 signaling cascade on Alzheimer’s disease pathology. He also worked as a Researcher at The Florey Institute of Neuroscience and Mental Health (Australia) studying sensorimotor processing in rodents.

Ruben Ruiz is a Health Biologist (BSc) who graduated in 2017 from Universidad de Alcalá from Madrid. He has a Master’s (MSc) in Neurosciences from Vrije Universiteit Amsterdam (VU Amsterdam).

Ruben is fluent in Spanish and English.

Catarina Santos is a Sr. Regulatory Affairs Scientist and an awarded and published author with a robust scientific background and Pharma experience. She is working on technical literature reviews and medical writing projects for clinical evaluations of medical devices and software according to MEDDEV 2.7/1 Rev 4 Guideline and EU Medical Device Regulations (MDR 2017/745).

Dr. Santos obtained her Ph.D. in Biomedical Sciences from the Universidad Autónoma de Madrid UAM.

She is a biochemist with two master’s degrees, one in Human Biology from the FCUL, and another in Clinical Research and Pharmaceutical Medicine from the EPHOS.

She is fluent in Portuguese, Spanish, and English.

Beatriz is a Regulatory Affairs Manager with an excellent scientific and international background and Pharma experience. Dr. Rodríguez obtained her Ph.D. in Neuroscience at the University of Manchester in England.

She is leading the Regulatory Team on technical literature reviews and medical writing projects ensuring compliance with regulatory guidelines.

Beatriz also has a bachelor’s degree in Biochemistry and two master’s degrees, one in Medical and Molecular Biosciences from the University of Newcastle-upon-Tyne, and another in Clinical Research and Pharmaceutical Medicine from EPHOS in Madrid. Prior to joining our company, she gained experience as a postdoctoral researcher at the University of Bordeaux, exploring the impact of traumatic brain injury in aging. Furthermore, she worked as a Medical Affairs Specialist in diabetes/NASH and Pulmonary Hypertension.

Beatriz is fluent in English, Spanish, and French.

Matias Fernandez is a Business Operations Manager responsible for building strategic clients and partner relationships. He is an experienced project and business management professional working with multicultural and multidisciplinary teams around the world.

Matias Fernández has a Master of Business Administration (MBA) from the University of Carlos III in Madrid (2020) and graduated from the Pontifical Catholic University of Chile with a degree in industrial, civil engineering with a focus in business administration.

Matias is fluent in Spanish, English, working-level Portuguese, and basic proficiency in German.

Esmeralda Gómez is a Corporate Resources and HR Manager with a strong background in Human Resources, MDR (EU) 2017/745 and Quality and Environmental Management Systems (ISO 9001, ISO 13485, ISO 14001).

Ms. Gómez is responsible for HR-related processes and corporate resources processes (such as 9001 implementation and cybersecurity).

Prior to joining our company, Esmeralda worked as HR & Quality Assurance & Regulatory Affairs administrator for 7 years in the MedTech sector.

Esmeralda is fluent in English and Spanish.

Almudena is our Corporate Resources Project Lead. She has both strong scientific knowledge and an interest in the business of setting up and running clinical trials.

Almudena has been involved in entrepreneurial projects involving in-vitro diagnosis systems and understands the complexity of “project launch to market” for technological products.

Almudena Millán is graduated in Biotechnology from Universidad Politécnica de Madrid in 2018.

She also has a Master’s in Business Administration (MBA) in Biotechnological Companies from Universidad CEU San Pablo from Madrid (2020).

José Vicente is a Regulatory Affairs Project Lead, leading technical literature reviews and medical writing projects for clinical evaluations of medical devices and in-vitro diagnostic devices.

José Vincente has a broad scientific background and research experience. He is an expert in performing systematic literature reviews according to MEDDEV 2.7/1 Rev 4 Guideline and EU Medical Device Regulations (MDR 2017/745) and in-vitro Diagnostic Device Regulations (IVDR 2017/746).

Prior to joining our company José Vicente worked at the Spanish National Cancer Research Centre (CNIO) in Structural Biology and Biocomputing.

José Vicente has an MSc in Biophysics from Universidad Autónoma (Madrid), a degree in Biotechnology from Universidad Francisco de Vitoria (Madrid), and a degree from the Athlone Institute of Technology (Ireland).

José Vicente is fluent in Spanish and English.

Maite Gómez Carvajal is a Clinical Research Associate with a strong background in Molecular Biology.

She is working on clinical projects performing site management and monitoring in compliance with ISO 14155:2020.

Maite has a Bachelor´s degree in Biomedical Sciences from the University of Lleida, Spain and a Master´s Degree in Molecular and Cell Biology. Prior to joining our company, she worked as a medical writer on projects related to clinical trials.

Maite is fluent in English, Spanish, Italian and French.

Elisa San Isidro is a Clinical Research Scientist Project Lead supporting the Clinical Operations Team. She also manages clinical trial submissions in Spain and is working as a CRA, performing site management and monitoring in compliance with ISO 14155:2020.

Elisa has a Bachelor’s in Science (BSc) in Biotechnology from Universidad Politécnica (Madrid) and laboratory experience at the CBGP Research Centre (Madrid).

She also has a Master (MSc) in Therapeutic Targets from Universidad de Alcalá (Madrid).

Miren Alustiza is a Clinical Research Scientist Project Lead with a strong background in academic research and pharma clinical trial experience. Dr. Alustiza obtained her Ph.D. in Experimental and Applied Biology from Universidad de Alicante in Spain.

Miren is working on clinical projects leading CA/CE submissions, document development, and performing site management and monitoring in compliance with ISO 14155:2020. She also supports the regulatory team in managing technical literature reviews.

Miren has a bachelor’s degree in Biomedical Science from Universidad de Lleida in Spain and, master’s degree in Biomedicine from Universitat de Barcelona in Spain. Prior to joining our company, she worked as a researcher studying systems for the extraction and analysis of healthy and colorectal cancer patients (CRC) fecal samples at the Hospital General Universitario de Alicante in Spain.

Miren is fluent in English, Spanish, and Basque.

Lucía García Inciarte is a Clinical Research Scientist – Project Lead. She has an excellent scientific and international background.

Lucía has over seven years of experience in clinical and biomedical research laboratories. She obtained her bachelor’s degree in Biochemistry from the Universidad de la República, Uruguay, and has a Master’s degree in Translational Medicine from the Universitat de Barcelona.

As a graduate researcher at BCNatal-IDIBAPS, Lucía studied cardiac remodelling in fetuses with intrauterine growth restriction. She is currently enrolled in an MBA program at Cerem Business school in Spain.

She is fluent in English and Spanish.

Íñigo Marquet is a Clinical Research Associate with a strong background in medical device engineering and biomedical research.

He is working on clinical projects performing site management and monitoring in compliance with ISO 14155:2020, as well as supporting the Clinical Operations team in document development and CA/CE submissions.

Íñigo has a bachelor’s degree in Biomedical Engineering from Universidad Carlos III in Madrid and laboratory experience at the Center for Biomedical Technology (Madrid). He also has a Master’s (MSc) in Therapeutic Targets from Universidad de Alcalá (Madrid).

Íñigo is fluent in English, Spanish and French.

Lucía Gato is a Clinical Research Scientist Project Lead with a strong scientific, statistical and biomedical background.

Dr. Gato obtained her Ph.D in Health Sciences with an FPU Fellowship in 2019 from Universidade de A Coruña in Spain. Part of her Ph.D. was also developed at the Institute of Transfusion Medicine and Immunology of Heidelberg University, Germany.

She is working on clinical projects performing site management and monitoring in compliance with ISO 14155:2020 and Medical Device Regulation (MDR 2017/745).

Lucía has a bachelor’s degree in Biology from the University of A Coruña. She has three master’s degrees, one in Health Research from the University of A Coruña, one in Human Reproduction from the University of Salamanca, and another in Clinical Trial Monitoring and Management from Complutense University of Madrid. Prior to joining our company, she worked as a researcher studying the use of a blood-derived preparation as an anti-inflammatory treatment for osteoarthritis at the Rheumatology Service of Complejo Hospitalario Universitario de A Coruña in Spain.

Lucía is fluent in English, Spanish and Gallician and has a basic level of German.

Mercedes is a Finance and Accounting Associate with a strong background in Human Resources and Economics.

She is working on Finance and Human Resources projects.

Mercedes studied a bachelor’s degree in Business Operations at Universidad de Alcalá de Henares (Madrid).

Mercedes is currently enrolled in a Master’s Degree in International Business with a Minor in Project Management in the university ENEB.

Mercedes is fluent in English, Spanish and French.

Katharina Peters is a Clinical Research Scientist – Project Lead with a strong background in Microbiology, Biochemistry and Biotechnology. Dr. Katharina Peters obtained her Ph.D. in Microbiology from the University of Kaiserslautern in Germany.

She is working on projects for clinical devices according to MEDDEV 2.7/1 Rev 4 Guideline and EU Medical Device Regulations (MDR 2017/745). Mrs. Peters is responsible for technical literature reviews and medical writing. She also performs clinical trial site management and monitoring in compliance with ISO 14155:2020.

Katharina has a Diploma in Microbiology from Kaiserslautern University in Germany. Prior joining our company she worked 6 years as Research Associate at the prestigious Centre for Bacterial Cell Biology and one year as Senior Research Associate at the School of Natural & Environmental Sciences at Newcastle University in UK. Her research focused on cell division, peptidoglycan synthesis and antibiotic resistance in different human pathogen bacteria.

Katharina has a very strong publication record and extensive experience in international and interdisciplinary collaborations.

Katharina is fluent in German (mother tongue), English and Russian and has basic knowledge of Spanish.

Alejandro Fulgencio Covián is a Clinical Research Scientist Project Lead with a strong
background in molecular biomedicine research.

Dr. Fulgencio obtained his Ph.D. in
Molecular Biology from Autonomous University of Madrid (Spain), and part of his Ph.D. was
completed at Leiden University Medical Center (LUMC) in the Netherlands.
He is working on clinical projects.

Mr. Fulgencio is responsible for site management and monitoring in compliance with ISO 14155:2020 and Medical Device Regulation (MDR 2017/745), as well as medical writing and document development.

Alejandro has a bachelor’s degree in Biochemistry and also has a master ́s degree in Molecular Biomedicine from Autonomous University of Madrid. Prior joining our company, he worked as a researcher studying the molecular alterations of the heart in inherited
metabolic disorders at Centro de Biología Molecular Severo Ochoa (CBMSO).
Alejandro is fluent in English and Spanish.

Álvaro Torcal is a Clinical Research Scientist Project Associate with a strong background in molecular biology and pharmacological research.

He is working on clinical projects supporting the Clinical Operations Team, performing site
management and monitoring in compliance with ISO 14155:2020.

Álvaro has a bachelor’s degree (BSc) in Biotechnology from Universidad Politécnica in
Spain and a master’s degree (MSc) in Pharmacological Research imparted by Universidad
Autónoma from Spain.

Prior to joining our company, he worked as a Research Assistant at
Zentrum für Medizinische Grundlagenforschung, Fundación Investigación Biomédica
Hospital Universitario La Princesa, and Instituto Fundación Teófilo Hernando.

Álvaro is fluent in English and Spanish and working-level in German.

Ángel Navarro is a Clinical Research Associate (CRA) Project Associate with a strong background in molecular biology.

He is working on submissions and monitoring projects.

Ángel has a bachelor’s degree in Biology from Universidad Complutense de Madrid and a
Master ́s Degree in Clinical Monitoring.

Prior to joining our company, he worked as a Study Coordinator in cardiology at Hospital 12 de Octubre.

Ángel is fluent in English and Spanish.