CardioMed is pleased to announce our partnership with the following regulatory, scientific, 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.
High Performance Computing (HPC) for MRI Safety, LLC – a US and European based consulting firm providing scientific and regulatory services to clients to achieve safe and effective Magnetic Resonance Imaging (MRI) labeling for medical devices. Our services include device design improvements for the MRI environment, MR safety training, computational and experimental MRI safety testing for all medical devices, development of standardized and specialized MRI safety test procedures, development of effective MR Conditional labeling, preparation of submissions to the US FDA and Notified Bodies, and support in all regulatory interactions.
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.