Meet the ÅKRN Team – the MedTech Experts

Grounded in medicine and science, we help sponsors move from medical discovery into clinical development, commercialization, and post-market follow-up.

We provide a high level of expertise, and excellent clinical and regulatory services, in a cost-conscious and diligent manner. Our experience covers a wide range of medical device therapeutic areas, including neuroscience and cardiovascular devices.

We are a multidisciplinary team collectively fluent in more than ten European languages. Our research specialists and clinical professionals have higher scientific degrees, including Ph.D., Pharm.D., and Masters in Clinical Research.

Our team specializes in medical devices and in-vitro diagnostics. We offer a single point of contact, but with the benefit of strong senior management support.

Our success builds upon providing our clients with a combination of medical and technical expertise within tightly controlled clinical studies and budgets. Because of this, our clients and partners view us as a trusted and valued adviser in clinical investigations and regulatory development, and CE-mark strategic consulting.

Maria Nyåkern, Ph.D. Founder & Executive Director LinkedIn

Diana Posa, Pharm.D Associate Director Clinical Affairs LinkedIn

Ariadna Navarro, Ph.D. Associate Director Quality & Regulatory Affairs LinkedIn

Matías Fernández, MBA
Business Development Manager LinkedIn

Raquel Cordeiro, Ph.D. Clinical Affairs Manager
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Ruben Ruiz, M.Sc.
Clinical Affairs Manager
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Elisa San Isidro, M.Sc. Clinical Study Manager
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Lucía García, M.Sc. Associate Manager Clinical Studies & IVD team lead
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Beatriz Rodríguez, Ph.D. Regulatory Affairs Manager
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José Velazquez, M.Sc.
Quality Assurance Manager LinkedIn

Catarina Santos, Ph.D. Sr. Regulatory Affairs Scientist
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Esmeralda Gómez Human Resources Manager
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Almudena Millán, MBA
Finance Specialist LinkedIn

Miren Alustiza, Ph.D.
Clinical Research Scientist
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Alejandro Fulgencio, Ph.D.
Clinical Research Scientist LinkedIn

Íñigo Marquet, M.Sc.
Clinical Research Scientist
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Maite Gómez, M.Sc. Clinical Research Associate
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Álvaro Torcal, M.Sc. Clinical Research Associate LinkedIn

Ángel Navarro, M.Sc. Clinical Research Associate LinkedIn

Laura Martínez, Ph.D. Clinical Research Scientist LinkedIn

Katharina Peters, Ph.D. Clinical Research Scientist
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Jairo Ruiz M.Sc. Associate Clinical Research Fellow LinkedIn

Marina Tapias, M.Sc. Regulatory and Clinical Research Fellow LinkedIn

Daniel Gil, Regulatory and Clinical Research Fellow LinkedIn

Emma Cordón, M.Sc. Regulatory and Clinical Research Fellow LinkedIn

Claudia Artiaga, M.Sc. Regulatory and Clinical Research Fellow LinkedIn

Joana Serrão, Ph.D.
Regulatory and Clinical Research Fellow LinkedIn

Violeta Lillo, B.Sc.
Regulatory Affairs Associate LinkedIn

Arancha López-Pérez, Ph.D.
Regulatory Affairs Scientist LinkedIn

Ana Margarita Maldonado, Ph.D.
Regulatory Affairs Scientist
LinkedIn

Albert Negrete, Ph.D.
Regulatory Affairs Scientist LinkedIn

Laura Martinez Campesino, Ph.D. Regulatory Affairs Scientist LinkedIn

Fernando Perlarda, M.Sc.
Associate Regulatory Consulting & Quality Assurance Fellow
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Izarne Medina, Ph.D.
Regulatory and Clinical Research Fellow LinkedIn

Jorge Delgado, M.Sc. Regulatory and Clinical Research Fellow LinkedIn

Sergio Vegas, Ph.D.
Regulatory and Clinical Research Fellow
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Julian Ortiz, MBA. Business Development Associate LinkedIn

Lucía Gonzalez, MBA.
Business Development Associate LinkedIn

Stefania Suarez, MBA. Business Development Associate LinkedIn

Mercedes Sánchez, MBA.
Finance Associate
LinkedIn

As Clinical and Regulatory Experts, we have the professional and ethical responsibility to maintain the highest standards of conduct when we exercise our professional duties. We take pride in upholding and clarifying the laws, regulations, and guidelines of the authorities under which we operate. We know that we play a pivotal role in ensuring compliance with applicable laws and regulations in the development and commercialization of healthcare products.

We honor our core values in this increasingly complex global clinical and regulatory environment. As individual professionals, we are making a positive contribution to public health. We also aspire to embody our code of ethics in our words, actions, and deeds.

The following values transpire in our everyday work.

• Regulatory Compliance
• Clinical Competency
• Credibility
• Objectivity
• Integrity
• Accountability
• Reason and Honesty
• Dignity and Respect

As the founder of the company, Maria Nyåkern, Ph.D., is an inspiring leader who steadily seeks to drive the field of clinical research consulting services forward. After completing her scientific training and doctoral studies in Sweden, Dr. Nyåkern spent 15 years in medical and clinical research in the medical device industry before founding AKRN Scientific Consulting.

AKRN is a CRO (Clinical Research Organization) focused on providing exceptional service and resources to the medical device and diagnostic industries. Our clinical scientists and project managers expediently guide and drive projects through the complete clinical development process through diligent planning and superior execution.

Clinical development can be risky in terms of timelines, so a good relationship and engagement of the CRO in the decision-making process are of crucial importance. The sponsor and the CRO should work hand-in-hand to accomplish established deliverables and allow innovative devices into the market faster. It is a long road that can only be achieved with a win-win scenario, with all parts working together to deliver new therapies to patients in a faster and more efficient way.

To date, AKRN is the trusted advisor and partner for many companies to deliver maximum value in their medical device development programs. AKRN is a privately-held European CRO, and since its inception, the company has experienced a fast and steady organic growth in employees and establishment in the European market.

Much of our work in the MedTech world is built on a desire to help others, and we work hard every day to deliver innovative and lifesaving technology. As successful members of the community, we also have a responsibility to help those that are less fortunate, and we need to contribute to the common good. For us, it is essential to give back to the communities in which we live and work. This is a cornerstone of our company philosophy.