ProVerum Limited

CardioMed Device Consultants is a medical device consulting firm specializing in regulatory strategy, clinical program design, quality systems, and pre-clinical testing for Class II and Class III medical devices, including implantable and interventional technologies. The firm provides end-to-end guidance across the total product life cycle, from IDE strategy through post-market compliance. Services include clinical trial oversight (design, vendor management, GCP compliance), FDA regulatory strategy and submissions, pre-clinical testing and biocompatibility assessment, quality systems design aligned with FDA QSR and ISO 13485, and customized regulatory training for clinical, engineering, and regulatory teams. CardioMed maintains a curated network of CROs, specialized laboratories, and subject matter experts for clinical execution, biostatistics, and advanced device testing. The company is senior-led with deep FDA experience and relationships across CDRH review teams.