GLOBAL MEDICAL DEVICE & IVD CRO
EU MDR | IVDR | FDA | CDSCO | UKCA
Accelerate your medical device or IVD approval with expert guidance in clinical investigations, regulatory submissions, and technical documentation.
Who We Are?
Bioexcel is a global Contract Research Organization (CRO) specializing in medical devices and in-vitro diagnostics (IVDs). We help manufacturers worldwide bring safe, high-quality products to global markets with full compliance.
We guide you through every critical stage of your product’s journey—from clinical investigations and clinical evaluations to regulatory submissions, technical documentation, PMCF (post-market clinical follow-up), and real-world evidence generation. Our approach emphasises simple processes, rapid turnaround times, and cost-effective solutions to help you achieve regulatory compliance efficiently and effectively.
SERVICES
Services We Offer
Clinical Investigation
Study design, protocol development, Ethics & regulatory submission, monitoring & site management, clinical study report
Clinical Evaluation Reports
Bioexcel assists clients in preparing thorough and well-documented reports that serve as essential components in the regulatory
PMS and PMCF (Retrospective & Prospective Study)
PMCF plan & report, PMCF survey & registries, pms plan & PSUR, real-world evidence collection
Performance Evaluation Report
Analytical, scientific & clinical performance, literature review & evidence appraisal, IVD classification & evidence strategy, PER gap analysis.
Materiovigilance
Strengthen patient safety & stay compliant with global post-market rules using VigiX, Bioexcel’s advanced materiovigilance platform
- Post-market safety monitoring of medical devices.
- Adverse event detection, recording & reporting.
- Trend analysis & signal detection.
- Field safety corrective action (FSCA) support.
- Incident reporting to authorities (EUMDR Annex III/CDSCO)
- Root cause analysis & CAPA recommendations
- Periodic safety update reports
- Device failure investigation support.
Bioexcel Medical Device Research Organization
Global Medical Device Research Organization
Guiding Medical Devices to Market Excellence
HOME SAMPLING
Diverse technologies with global impact
Bring to the table win-win survival strategies to ensure proactive domination and at the end of the day.
VISION
Driving innovation in emerging healthcare technologies by delivering precise clinical data to diagnose health challenges and provide value to patients, healthcare providers, and systems worldwide.
MISSION
To empower medical device innovators by providing end-to-end support throughout the development journey from concept to market excellence. Our focus remains on ensuring safety, precision, and improved outcomes for patients and society at large.
CORE VALUES
Trust, Teamwork, Human Values, Ethical Standards, Passion, Integrity, Continuous Development.
Phases
Therapeutic Areas We Work In
Cardiology
Cardiology
Orthopedics
Orthopedics
Neurology
Neurology
Oncology
Oncology
Ophthalmology
Ophthalmology
Respiratory Care
Respiratory Care
SERVICES
FULL SERVICE CONTRACT RESEARCH ORGANIZATION FOR MED-TECH INDUSTRY
Client Focused,Flexible And Also Cost Effective.
- Expertise to Deliver Exceptional Results
- Highest Quality Results
- Real World Data in Evaluating Device & Patient Safety
- Led by Passionate Experts to Support Your Clinical Trial Journey at Any Point
- Xceltrials in-house trial management solution to improve clinical study outcomes
- Driven to Deliver Expectational Results
Testimonials
What Clients Say About Us
GET IN TOUCH
Performed By Highly Qualified & Experienced Team
Clinical studies as per ICH GCP & ISO 14155
Get in Touch with us
Services
Clinical Trial Services
Clinical Development Services for Medical Devices
End-to-end clinical trial solutions to fast-track your medical device to market-
Trial Design & Planning
-
Protocol Development
-
Adaptive Trial Design
-
Clinical Trial Planning & Monitoring
-
Site Selection and Management
-
Execution & Monitoring
-
Patient Recruitment and Retention
-
Site Training and Support
-
Quality Assurance and Auditing
-
Data Analysis & Reporting
-
Clinical Data Management
-
Biostatistics and Data Analysis
-
Medical Writing
Regulatory Compliance & Licensing Support
Effortless regulatory services for CE, FDA, and manufacturing licenses-
Device Documentation
-
Technical File Preparation
-
Clinical Evaluation Reports (CER)
-
Instruction for Use of IFU & labels
-
Licensing & Classification
-
Manufacturing License
-
Test License
-
Product Classification
-
Import License
-
Global Approvals
-
CE Marking for All Device Classes
-
Post-Approval Changes
-
US FDA 510(k) Submissions
Materiovigilance & Post-Market Surveillance
Real-time device safety and compliance with expert post-market surveillance and risk management.-
Narratives preparations
-
Manufacture Incident Reports
-
Post- Market surveillance Plan
-
Customer Complains
-
Medical device reporting
-
Risk Management
-
PMCF Plan & Evaluation Report
-
Post Market Surveillance Report
-
Adverse Device Effect
-
Field Safety Corrective action
-
Case Processing & follow up
-
Medical Device Incident
