MEDIcept

MEDIcept is a Massachusetts-based medical technology consultancy and CRO focused on devices, IVDs, combination products and digital health. It supports FDA strategy, pre-submissions, 510(k), De Novo and PMA applications, establishment registration and post-market reporting. Its global services also cover EU MDR and IVDR technical documentation, clinical evaluation reports, quality systems, audits and clinical study planning and execution.