About Bioexcel
Bioexcel is a MedTech Clinical Research Organization (CRO) supporting medical device and IVD manufacturers across the product lifecycle.
Headquarters
Nagpur, MaharashtraWebsite
- Company Size
11-50 employeesIndustry
Research ServicesCompany Type
Privately HeldFounded
2020Specialties
Clinical Investigations (ISO 14155), EU MDR & IVDR Compliance, Post-Market Clinical Follow-up (PMCF), Clinical Evaluation Reports (CER), Biological Evaluation Reports (BER), Regulatory Strategy for CE Marking & US FDA, CDSCO Registration & Test License (India), ISO 13485:2016 QMS Implementation & Audit Support, Risk Management (ISO 14971), Materiovigilance & PMSR Development, Literature-Based Performance Evaluation, Custom Protocol Design & CRO Services, EDC Software for Clinical Trials – XcelTrials, Notified Body & Ethics Committee Liaison, and Startup Regulatory Support & Technology Transfer