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 2015 after working nearly 15 years in the regulatory and clinical development of medical device technology and commercialization of healthcare products.
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 14155:2019 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 director of clinical operations and development of new business. 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 & Regulatory Affairs Lead. Ms. Posa is responsible for ensuring the appropriate coordination of the ethics committee and regulatory authority submissions in Europe. She is also managing the on-boarding of new CRAs and leading the training of new staff on Clinical Investigations according to Good Clinical Practice, ISO 14155 Standard, and the EU Medical Device and IVD Regulations.
Diana has a 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 our Clinical Operations Lead. She is responsible for coordinating projects and resources to ensure timelines and deliverables are met in a timely manner. Ariadna is also our lead for coordinating MDD to MDR and IVDD to IVDR regulatory gap analysis and medical writing projects.
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 a 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 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 research scientist 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 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) graduated in 2017 from Universidad de Alcalá from Madrid. He has a Master (MSc) in Neurosciences from Vrije Universiteit Amsterdam (VU Amsterdam).
Almudena Millán, M.Sc.
Almudena is our Business Development and Operation Assistant. 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 of involving in-vitro diagnosis systems and understand the complexity of “project launch to market” for technological products.
Almudena Millán is graduated in Biotechnology from Universidad Politécnica de Madrid in 2018.
She is finishing a Master’s in Business Administration (MBA) in Biotechnological Companies from Universidad CEU San Pablo from Madrid.
Roberto Estébanez, M.A.
Roberto Estebanez is Director of Finance with operational and strategic roles in managing accounting and financial control functions to establish a financial strategy for the profitable long-term growth of the business.
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 finance controller, he also has the responsibility for managing employee contracting and keeping employees in compliance with national labor laws.
Roberto has Master of Arts (M.A) degree in Psychology (2015) and a Master in Clinical Psychology. He also has a degree in Journalism (1998) and is the founder of 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 has a
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). He is fluent is Spanish and English.
Raquel Cordeiro, Ph.D.
Raquel Cordeiro is a Clinical Research Scientist leading European clinical study projects.
Dr. Cordeiro has a broad international scientific experience and excellent project management skills.
Raquel 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).
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. At that time, she was working in structural biology and biocatalysis. 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 four languages; Portuguese (mother tongue), English, Spanish, and German.
Elisa San Isidro, M.Sc.
Elisa San Isidro is a Clinical Trial Assistant supporting the Clinical Operations Team. She has a great mixture of organizational and scientific skills. She also supports the Business Development team, working on medical marketing research projects, creating medical content using reliable scientific sources.
Elisa has a Bachelor’s in Science (BSc) in Biotechnology from Universidad Politécnica (Madrid) and laboratory experience at the CBGP Research Centre (Madrid).
Eisa is currenlty finishing a Master (MSc) in Therapeutic Targets from Universidad de Alcalá (Madrid).
Ana Manuela de la Pedrosa, Ph.D.
Ana Manuela de la Pedrosa is Clinical Trial Assistant and junior CRA. She is also supporting clinical projects to continuously improve processes, tools, systems, and organization.
Ana Manuela has a life science background and ISO 9001 quality experience. She has a Master of Science (MSc) graduated in 2015 and she is currently finalizing a Ph.D. at the Universidad Autónoma of Madrid.