CardioMed is pleased to announce our partnership with the following regulatory and clinical organizations:
Psephos Biomedica – is a European based clinical, regulatory and quality consulting firm that works with clients to bring the latest, innovative medical technologies to market. Psephos’ services provide clients with integrated support from concept to CE Marking, commercialization and beyond including development of strategic plans, Technical Files, Design Dossiers, Quality Management Systems, Clinical Evaluation Reports, Risk Management activities, Notified Body & Competent Authority interactions, Post-Market Clinical Follow-up and Post-Market Surveillance.
QMed Consulting A/S – a European based full service medical device Contract Research Organization (CRO) providing clinical trial management, regulatory and re-imbursement services in Europe. Our key services include Clinical Evaluation reports, Review of Technical files, Risk Management, clinical document preparation, site selection, Ethics/Competent Authority submissions, study management, safety reporting, data management, biostatistics and reimbursement services.
These partnerships will facilitate the global provision of insightful advice and collective experience necessary for the development of cardiovascular medical devices from innovation solutions to the clinical management of cardiac and vascular diseases.