Accelerating Medical Device Innovation, Globally.
At Bioexcel, we partner with medical device and IVD companies to navigate the complex journey from prototype to regulatory approval with confidence. As a global Clinical Research Organization (CRO), we specialize in EU MDR, IVDR, US FDA, and CDSCO compliance — providing tailored solutions that meet the highest standards in safety, performance, and post-market surveillance.
Whether you’re launching a new device or updating your technical documentation, Bioexcel supports you every step of the way — from clinical investigations, PMCF planning, and CER/BER development to materiovigilance and ISO 13485 QMS implementation.
We’re also the creators of XcelTrials – a purpose-built EDC platform that streamlines PMCF, PMS, and regulatory documentation with real-time insights and global compliance tracking.
Company Details
- Employees
- 31
- Founded
- -
- Address
- Plot No. 24, Vaibhavanand Society, Ganapati Nagar, Zingabai Takli, Nagpur,maharashtra 440030,india
- Industry
- Research Services
- NAICS
-
Scientific Research and Development ServicesResearch and Development in the Physical, Engineering, and Life SciencesResearch and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology)
- Website
- http://www.bioexcelife.com
- Keywords
- 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, Startup Regulatory Support & Technology Transfer.
- HQ
- Nagpur, Maharashtra
- Competitors
- Clinical Research Management (CRM) Network, Canvass Clinical Research Services Pvt.Ltd | Site Management Orgnization ( SMO)| Research institute, KV CLINICAL RESEARCH PVT LTD( Site Management Organization), Cliantha Research Limited, BioExcel LLC, Avanvi Research and Technologies Pvt Ltd, BioExcel CoE, Hector Research and Archival Private Limited | Site Management Organization (SMO), CURO BIOSCIENCES PRIVATE LIMITED, ClinTrek Research Pvt. Ltd. & ClinTrek Research LLC.
Bioexcel Questions
Bioexcel's website is http://www.bioexcelife.com
Bioexcel's LinkedIn profile is https://in.linkedin.com/company/bioexcelife
Bioexcel has
31 employees.
View email and phone details for 31
employees at Bioexcel.
Bioexcel's industry is
Research Services
Bioexcel's top competitors are
Clinical Research Management (Crm) Network,
Canvass Clinical Research Services Pvt.ltd | Site Management Orgnization ( Smo)| Research Institute,
Kv Clinical Research Pvt Ltd( Site Management Organization),
Cliantha Research Limited,
Bioexcel Llc,
Avanvi Research And Technologies Pvt Ltd,
Bioexcel Coe,
Hector Research And Archival Private Limited | Site Management Organization (Smo),
Curo Biosciences Private Limited,
Clintrek Research Pvt. Ltd. & Clintrek Research Llc.
Bioexcel's categories are Research Services
Bioexcel's founding year is 2020
