Bioexcel
Bioexcel provides end-to-end regulatory affairs support for Medical device and in vitro diagnostic (IVD) manufacturers navigating complex global regulatory frameworks.
We help companies define the right regulatory pathway, prepare compliant documentation, and manage regulatory interactions to achieve timely approvals and sustained compliance across multiple markets.
Our Regulatory Approach Is
- Evidence-driven and inspection-focused
- Ensuring alignment between clinical evidence
- Technical documentation
- Post-market obligations under current regulatory expectations.
WHAT WE SUPPORT
- European Union: EU MDR & IVDR
- United States: FDA (510(k), De Novo, PMA)
- India: CDSCO (Medical Device Rules)
- United Kingdom: UKCA
- Global Markets: Strategic support for international pathways.
WHY BIOEXCEL FOR REGULATORY AFFAIRS
- Exclusive focus on Medical Devices & IVDs
- MDR, IVDR, ISO 14155 and GCP-aligned processes
- Regulator- and Notified Body-aligned documentation approach
- Seamless integration of regulatory, clinical, and digital workflows
REGULATORY + CLINICAL ALIGNMENT
Integrated Regulatory & Clinical Evidence Approach
Regulatory success depends on the quality and alignment of clinical evidence. Bioexcel ensures that regulatory strategies are tightly integrated with:
- Clinical Investigations
- Clinical Evaluation Reports (CER)
- IVD Performance Evaluation (PER)
- PMCF and Post-Market Evidence
DIGITAL SUPPORT FOR REGULATORY COMPLIANCE
Digital Enablement of Regulatory Compliance
Post-market surveillance and vigilance activities required by regulators can be managed using VigiX™, Bioexcel’s digital compliance platform.
VigiX™ supports:
- PMS & PSUR preparation
- Vigilance and incident reporting
- Trend analysis and signal detection
- Inspection-ready audit trails
Navigate Global Regulations with Confidence
- Whether you are planning initial market entry or managing ongoing regulatory obligations
- Bioexcel helps you move forward with clarity and compliance.
