Global Clinical Investigation & Evidence Generation EU MDR|ISO 14155|FDA| CDSCO Compliant

Supporting EU MDR, FDA & Global Regulatory Submissions

  • From Study Design to Final Clinical Study Report
  • End-to-End Clinical Strategy, Execution & Reporting

Clinical Investigation Services for Medical Devices

Bioexcel provides EU MDR–compliant clinical investigation services for medical devices to generate robust, regulator-ready clinical data. All studies are designed and conducted in accordance with ISO 14155:2020, ensuring patient safety, data integrity, and Notified Body acceptance.

Clinical Investigation Capabilities

We support manufacturers across the complete clinical investigation lifecycle for medical devices and combination products.

  • Clinical investigation feasibility & strategy
  • Clinical Investigation Plan (CIP) development
  • Ethics Committee & regulatory submissions
  • Site selection, initiation & monitoring
  • Data management and quality oversight
  • Clinical Investigation Report (CIR) preparation

EU MDR & ISO 14155 Regulatory Compliance

Our clinical investigations strictly align with:

  • EU MDR (Regulation (EU) 2017/745)
  • ISO 14155:2020 – Clinical investigations of medical devices
  • ICH-GCP principles (where applicable)
  • Country-specific regulatory and ethics requirements

This ensures generated clinical data can be directly used in CE marking submissions.

Linkage to Clinical Evaluation & PMCF

Clinical investigation data generated by Bioexcel supports:

  • Resolution of CER clinical data gaps
  • High-risk and innovative device approvals
  • Strengthening Notified Body review outcomes
  • Lifecycle evidence through PMCF and PMS
  • Clinical Evaluation Reports (CER)
  • PMCF & PMS Services

Technology-Enabled Clinical Trials (Xceltrials™)

Bioexcel uses Xceltrials™, our clinical trial and evidence management platform, to deliver:

  • Structured data capture
  • Audit-ready documentation
  • End-to-end traceability across clinical evidence
  • Xceltrials™ Clinical Evidence Platform

Why Bioexcel as Your Medical Device CRO?

Medical Device CRO

  • Exclusive focus on medical devices & IVDs
  • Proven experience with EU MDR clinical expectations
  • Cost-effective global execution
  • Integrated CRO + regulatory + digital platform model