Miren Fernandez's Contact Details

Miren Fernandez's Company Details

ÅKRN, Now Part of NAMSA

Madrid, Community of Madrid, Spain • 45 Employees
Medical Devices

AKRN Scientific Consulting is a clinical research and regulatory consulting firm for medical devices and IVD.AKRN is based in Spain and Sweden. We provide clinical development services on a stand-alone basis, or as part of an integrated full-service solution together with our European CRO-partners. Our clients include MedTech start-up companies as well as multi-national companies. We are committed to partner with Medical Device companies developing innovative technologies improving health care for more people. We are highly qualified, experienced, and accountable clinical research professionals that guarantee cost-effective and successful solutions crafted to each client's needs. We combine therapeutic expertise and decades of industry know-how with excellent service and responsiveness to support our customers with solutions that can stand up to rigorous scientific and regulatory evaluations.We follow the national and international current standards (ICH/GCP guidelines, European regulations, and national and regional legislation), and the client or AKRN internal SOPs.Services:-Clinical Trial Services-Clinical Strategy and Planning-Study Design-Clinical Monitoring-Post Market Clinical Follow Up PMCFRegulatory Services:-CE Mark Strategic Planning-Technical File | Design Dossier-EU MDD to MDR Transition -EU IVDD to IVDR Transition-Clinical Evaluation Report CERKey Medical Areas:In-Vitro Diagnostic IVDCardiovascular-Heart Valve Disease-Aortic Disease-Atrial Fibrillation-Coronary Artery Disease-Hypertension-Endovascular Aortic Repair EVAR-Percutaneous Coronary Interventions PCI-Transcatheter Aortic Valve Implantation TAVINeurovascular-Neuromodulation-Spinal Cord Injuries-Neurovascular Mechanical ThrombectomyGeneral-Critical Care and Sepsis Management-Minimal Invasive SurgerySoftware-AI | Machine Learning -MDSW | SaMDOdontology-Implant and Digital DentistryEndocrinology-Endocrinology and Diabetes