Bioexcel
Medical Device CRO for regulatory and clinical compliance, specializing in EU MDR and IVDR.
Bioexcel provides specialized CRO services for medical devices and in vitro diagnostics (IVDs). It supports companies across the device lifecycle, focusing on clinical, regulatory, and digital compliance. The services are tailored to meet EU MDR, IVDR, FDA, and other global regulatory standards.
Key Services:
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Clinical & CRO Services: Offers comprehensive clinical evidence generation, including EU MDR clinical investigations, Clinical Evaluation Reports (CER), IVDR Performance Evaluation Reports (PER), and post-market studies.
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Regulatory Affairs: Provides strategic planning, technical documentation, and global submission management for EU MDR, IVDR, FDA, CDSCO, and UKCA frameworks.
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Digital Compliance Platforms: Utilizes Vigi X™ and Xceltrials™ for audit-ready automation in clinical trials, PMS, PSUR, and vigilance reporting.
Bioexcel stands out with its platform-enabled solutions that replace manual processes with structured digital workflows, ensuring compliance and efficiency. It supports a wide range of medical device segments, including cardiology, orthopedics, neurology, oncology, ophthalmology, respiratory care, and more.
The company is trusted by global medical device manufacturers for its technical competence and commitment to quality. With over 100 projects across 20+ countries, Bioexcel is a reliable partner for navigating complex regulatory environments.
