Maria Nyåkern, Ph.D.
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
David Tomé, M.Sc., MBA
David Tomé is the COO and director of business development. He is responsible for the day-to-day activities and coordination of staff and projects.
David is an experienced commercial operation professional with over 10 years of experience in the medical devices and pharma sector. He has a strong background in using evidence-based medicine as a foundation for building marketing and sales strategies to interact with commercial teams, key buyers, and opinion leaders to establish win-win long-term relationships.
David has an M.Sc. in Environmental Biology from Universidad de Alcalá in Madrid (2006) and a Master of Business Administration (MBA) from the University of Carlos III in Madrid (2018). In addition, he has spent several years in academic research, including at the International Antarctic research station and as a research partner for the NASA Curiosity Mars Project.
Diana Posa, Pharm.D.
Diana Posa Podean is a Clinical Research Scientist and our Clinical Affairs Manager. Ms. Posa is responsible for ensuring the appropriate coordination of the ethics committee and regulatory authority submissions in Europe. She is also managing the team of CRAs and leading the training on Clinical Investigations according to Good Clinical Practice and ISO 14155 Standard.
Diana has strong experience in literature reviews and medical writing projects for clinical evaluations of medical devices according to MEDDEV 2.7/1 Rev 4 and has successfully prepared several Clinical Evaluation Reports (CER) resulting in CE-mark certification.
Diana has a strong scientific background and prior to joining our company, she worked as a Research Scientist at CIB-CSIC Research Institute (Madrid) studying the lethal neurodegenerative disease ALS and as a Clinical Data Coordinator at Hospital Universitario Príncipe de Asturias (Madrid).
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, Ph.D.
Ariadna Navarro is a Clinical Research Scientist and Regulatory Affairs Manager. Ariadna is also our lead for coordinating MDD to MDR and IVDD to IVDR regulatory gap analysis and medical writing projects. She is also leading the training of new hires to ensure compliance with EU Medical Device and IVD Regulations.
Dr. Navarro is an experienced clinical research professional with excellent scientific expertise as well as strong project management and leadership capabilities. She has expert knowledge in European Device Regulations and GCP and ISO 14155 and ISO 20916 Standards.
Dr. Navarro has a strong background in biomedical research and prior to joining our company, she worked as a Researcher at University College London (UK) studying cardiovascular development and as a Molecular Geneticist developing new diagnostic tools for neurodegenerative diseases at Hospital Germans Trias i Pujol (Barcelona).
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 has a Ph.D. in Cardiovascular Sciences (UCL, 2019).
Ariadna is fluent in Spanish, English, and Catalan.
Jorge Medina, Pharm.D.
Jorge Medina is a Clinical Research Scientist and our Clinical Quality Lead. Jorge Medina is also an expert on the Spanish ethics committee and regulatory authority (AEMPS) submissions. He is working in clinical project management, and as the quality lead for projects controlling and monitoring clinical study compliance with the ISO 14155 GCP Standard. Jorge is also leading literature reviews and medical writing projects for clinical evaluations of medical devices, according to MEDDEV 2.7/1 Rev 4 Guideline and EU Medical Device Regulations (MDR 2017/745).
Jorge has a strong scientific background. Before joining our company, he worked as a Research Scientist at Aalborg University Hospital (Denmark) studying the proteomic changes of lung cancer cells under hypoxia and the hypercoagulable profile of lung cancer patients.
Jorge Medina is a Doctor of Pharmacy (Pharm.D) who graduated in 2016, and he has a Master in Medicine with Industrial Specialisation in Translational Medicine from Aalborg University (Denmark, 2018).
Jorge is bilingual in Spanish and English and has a basic working level in Danish, Japanese, and Mandarin.
Amalia Meseguer, Pharm.D.
Amalia Meseguer is a Clinical Research Scientist with strong experience in project management of Clinical Investigations according to GCP 14155 Standard. Ms. Meseguer is responsible for clinical trial site management and monitoring in France, Germany, and Benelux.
She is also leading literature reviews and medical writing projects for clinical evaluations of medical devices according to MEDDEV 2.7/1 Rev 4 Guideline and EU Medical Device Regulations (MDR 2017/745).
Amalia Meseguer has a strong scientific background and a Pharma experience. Prior to joining our company, she worked as a Medical Affairs Specialist and Clinical Patient Project Manager.
Amalia is a Doctor of Pharmacy (Pharm.D) who graduated in 2016 and she has a Master of Monitoring and Clinical Research from EPHOS (2017).
Amalia is fluent in Spanish, English, French, and basic proficiency in German.
Ruben Ruiz, M.Sc.
Ruben Ruiz is a Clinical Affairs Project 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.
Almudena Millán, M.Sc., MBA
Almudena is our Business Development and Operation Associate. She has both strong scientific knowledge and 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).
Roberto Estébanez, M.A., LCP
Roberto Estebanez is the CFO and Director of Finance with an operational and strategic role in accounting and financial control to establish a strategy for the business’s profitable long-term growth.
Roberto has a strong entrepreneurial background and has started several companies in the healthcare sector, which gives him the versatility and talent to meet a continually changing set of circumstances in the MedTech sector. As a finance controller, he also has the responsibility to manage employee contracting and ensure compliance with national labor laws.
Roberto is a Licensed Clinical Psychologist (LCP) and has a Master of Arts (M.A) degree in Psychology (2015) and a Master in Clinical Psychology (2017). He also has a Master’s Degree in Journalism (1998).
He is the founder and owner of Keyles Consulting (2011), Disline Communicaciones (2008), and the digital newspapers Diario de la Ribera (2005) and Diario de Sanse (2019).
José Velázquez, M.Sc.
José Vicente is a Clinical Research Scientist 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.
Raquel Cordeiro, Ph.D.
Raquel Cordeiro is a Clinical Operations Manager leading European clinical study projects. She also performs clinical trial site management and monitoring in compliance with ISO 14155:2020. Raquel Cordeiro is a Clinical Research Scientist leading European clinical study projects.
Dr. Cordeiro has broad international scientific experience and excellent project management skills.
Raquel is also 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).
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.
Elisa San Isidro, M.Sc.
Elisa San Isidro is a Clinical Research Scientist 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).
Matias Fernandez, MBA
Matias Fernandez is a Marketing Research Associate 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.
Catarina Santos, Ph. D
Catarina Santos is a Regulatory Affairs Project Manager, 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.
Ainhoa Pardo, BA.
Ainhoa Pardo is our Digital Marketing Associate with a strong background in sales and customer service, acquiring the ability to understand the market, ensuring customers’ needs, and business objectives.
Ainhoa Pardo has a Bachelor’s degree in Marketing from Facultad de Ciencias Económicas y Empresariales de la Universidad del País Vasco (UPV/EHU) and, she is specializing in the Master of Digital Marketing and E-commerce at EAE Business School.
She is fluent in Spanish, English, and Basque.
Ana Bidovec, BA.
Ana Bidovec is our Finance and Legal Assistant with a strong international background in accounting software and applications experience along with the abilities of technical finance and commercial acumen. Ana is also specializing in the Master of Law from The Unir University in Spain, providing AKRN with legal and juridical facilities.
She is working conjointly with the Business Operation team managing and processing invoices and fiscal documentation.
Ana has a Bachelor’s degree in Accounting and Finance from ESIC Business & Marketing School in Spain. Prior to joining our company, she specialized in International Law and Legal Studies at Lingnan University (Hong Kong). Therefore, she worked as a paralegal studying business and international law as well as client relations in Slovenia.
Ana is fluent in English, Spanish, and Slovenian.