AKRN Scientific Consulting is a clinical research and regulatory consulting firm for medical devices and IVD. 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 Investigatio -Clinical Strategy and Planning -Study Design -Clinical Monitoring -Post Market Clinical Follow Up PMCF Regulatory Services: -CE Mark Strategic Planning -Technical File | Design Dossier -EU MDD to MDR Transition -EU IVDD to IVDR Transition -Clinical Evaluation Report CER Key Medical Areas: * In-Vitro Diagnostic IVD * Cardiovascular -Heart Valve Disease -Aortic Disease -Atrial Fibrillation -Coronary Artery Disease -Hypertension -Endovascular Aortic Repair EVAR -Percutaneous Coronary Interventions PCI -Transcatheter Aortic Valve Implantation TAVI *Neuromodulation *Neurovascular Mechanical Thrombectomy * Critical Care and Sepsis Management * Software: AI & Machine Learning (MDSW | SaMD) * Odontology: Implant and Digital Dentistry * Endocrinology