AKRN Scientific Consulting
- A. Health Biotechnology
- Areas of activity
- In vitro diagnostics
- Diagnostic imaging
- Medical devices
- Drug delivery
- Therapeutic areas
- Cardiovascular diseases and circulatory system
- Gynaecology and obstetrics
- Ophtalmology and optometry
- Central nervous system
- Respiratory and pulmonary system
- D. Services
- R&D services
- CRO / CMO / SMO
- Professional services
AKRN Scientific Consulting, a medical device consulting firm, provides clinical research and regulatory affairs services.
AKRN experts' knowledge of the MedTech sector supports our clients' clinical assessment and regulatory strategies to demonstrate safety and performance before and after entering the European market.
AKRN works to optimize the times and costs of clinical evaluation, key parameters for medical technology start-ups, where clinical milestones must be reached in time and quality to demonstrate the value of innovations and ensure the success of the following rounds of financing.
The most demanded services are:
- Design and management of clinical trials for class I, class II and class III medical devices, within the framework of MDR 2017/745
- Clinical Evaluation Report (CER)
- Post Market Clinical Follow Up (PMCF) and Post Market Surveillance Plan and Periodic Safety Update Report. (PMS and PSUR)
- Transition between regulatory frameworks. From MDD to MDR.
- Regulatory Strategy
AKRN's success is based on the specialization of the medical device together with the tailored services for SMEs and start-ups in the sector, offering a high-level technical collaboration with strictly controlled budgets.
- Medical Devices
- Structural Heart Repair
- In-Vitro Diagnostics (IVD)
- Atrial Fibrillation
- Spinal Cord Injuries
- Implant and Digital Dentistry
- Endocrinology and Diabetes
- Sepsis Management
- AI/Machine Learning SaMD
- Minimally Invasive Surgery
- Endovascular Aortic Repair (EVAR)
- Percutaneous Coronary Interventions (PCI)
- Transcatheter Aortic Valve Repair (TAVR)
- Neurovascular Mechanical Thrombectomy