Company Performance Metrics
BioVision provides regulatory, quality assurance, and clinical consulting services for medical device companies. The company focuses on medical device regulatory affairs, including FDA submissions such as 510(k), IDE and PMA, EU MDR and CE marking, and global registrations across multiple jurisdictions. BioVision designs and implements quality
management systems aligned with FDA QMSR, ISO 13485 and related standards, and performs audits, corrective action reviews and quality system maintenance. Its consultants support pre-clinical and clinical affairs, including clinical strategy, study planning and post-market clinical follow-up. BioVision also offers outsourcing of regulatory and quality professionals, due diligence audits, and advisory services for AI-based medical device regulation. Its services cover the full device lifecycle from development through post-marketing compliance.
