AKRN Scientific Consulting, a medical device consulting firm, provides clinical research and regulatory affairs services.

The MedTech sector knowledge of AKRN's experts underpins our clients' regulatory and clinical evaluation strategies to demonstrate safety and performance before and after entering the European market.

AKRN works to optimize clinical evaluation times and costs, key parameters for MedTech startups, where clinical milestones must be reached in time and quality to demonstrate the value of innovations and ensure the success of subsequent funding rounds.

AKRN's success is based on the specialization of the healthcare product together with tailor-made services for SMEs and start-ups in the sector, offering a high technical level of collaboration with strictly controlled budgets.

“We want to work in partnership with medical device manufacturers creating breakthrough products to provide patients with safe and effective treatment solutions.”

  • Area of Activity
  • Metabolic system - endocrinology
  • Research services and supplies
  • CRO - CMO Services
  • Oftalmology
  • Neuroscience
  • Sales & Marketing
  • Neurologic Diseases
  • Medical Devices
  • Software development
  • Consultancy
  • Cardiovascular and circulatory system
  • Bioinformatics
  • Company type
  • Health Biotechnology
  • Services and consulting for biotech sector
  • Technology Services
Calle Fuerteventura 4 (Oficina 1.8)
San Sebastián de los Reyes, Madrid 28703, ES
P: +34 616 76 19 56

President and CEO: Maria Nyåkern

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

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 master’s 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 expertise includes safety and performance studies and post-market clinical follow-up studies. We can be your bridge to key opinion leaders and surgical experts throughout Europe.

·Clinical services

·Regulatory services

·Medical writing

·Data management

·Statistical Analysis and reporting

·Medical Device training

Activity areas:

·Structural Heart Repair


·Endocrinology and Diabetes

·Endovascular Aortic Repair (EVAR)

·In-Vitro Diagnostics (IVD)

·Spinal Cord Injuries

·Sepsis Management

·Percutaneous Coronary Interventions (PCI)

·Atrial Fibrillation


·Al/Machine Learning SaMD

·Transcatheter Aortic Valve Repair (TAVR)


·Implant and Digital Dentistry

·Minimally Invasive Surgery

·Neurovascular Mechanical Thrombectomy

A team built on medical device expertise, providing medical and technical expertise in a diligent and cost-conscious manner.

We embody our code of ethics in our words, actions, and deeds and honor our pivotal role in the increasingly complex global clinical and regulatory world, ensuring that we are making a positive contribution to public health.

Our main clients are manufacturers who need support and assistance throughout the whole process to enable their medical devices to enter the European market, as well as to comply with all the necessary EU regulations. Furthermore, we offer optimized regulatory and clinical services tailored to MedTech partners, for instance, pharmaceuticals, start-up accelerators, other CROs, and academic institutions.

AKRN Scientific Consulting