Supporting EU MDR, FDA & Global Regulatory Submissions — from Study Design to Final Clinical Study Report, with 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, regulatory-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?
- Exclusive focus on medical devices & IVDs
- Proven experience with EU MDR clinical expectations
- Cost-effective global execution
- Integrated CRO + regulatory + digital platform model
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, with end-to-end clinical strategy, execution & reporting.