Clinical, Regulatory & Digital Compliance Partner for Medical Devices and IVD Companies

End-to-end support across the Medical Device & IVD lifecycle — from Clinical Investigation and Clinical Evaluation to Global Regulatory Approval and Post-Market Compliance.

  • EU MDR & IVDR Clinical Evidence Experts
  • CER,PER,PMCF & Global Regulatory Submissions
  • Platform Enabled Materiovigilance & Clinical Trial Automations

What We Do?

Clinical & CRO Services

Clinical investigations, CER, PER, PMCF, PMS, and real‑world evidence for medical devices and IVDs.

Regulatory Affairs

End‑to‑end regulatory strategy and submissions across EU, US, India, UK, and global markets.

Digital Compliance Platforms

Audit‑ready software for clinical trials, post‑market surveillance, and vigilance reporting.

Services We Offer

Clinical & CRO Services

End-to-end clinical evidence generation to support regulatory approvals and ongoing compliance under EU MDR, IVDR, US FDA, CDSCO, and global frameworks.

Regulatory Affairs Services

Strategic regulatory guidance and submission support across EU MDR, IVDR, US FDA, CDSCO, UKCA, and global regulatory pathways.

Technical & Quality Services

Regulatory-aligned technical documentation, risk management, and quality support designed to meet EU MDR, IVDR, and global medical device requirements.

Digital Compliance Platform

Digital compliance platforms for medical devices and IVDs. Vigi X™ for PMS & vigilance and Xceltrials™ for clinical evidence management.

Our Applications Cover Diverse Corporate Markets

Global Medical Device Research Organization

Bioexcel Medical Device Research Organization
Guiding Medical Devices to Market Excellence

Therapeutic Areas We Work In

Cardiology

Cardiac implants, Heart rhythm management devices, Diagnostic imaging tools for cardiovascular health.

Orthopedics

Bone implants and fixation devices, Spinal implants and devices, Sports medicine and rehabilitation solutions.

Neurology

Neuromodulation devices, Stroke and brain injury diagnostic devices, Devices for Parkinson’s, epilepsy, and Alzheimer’s

Oncology

Biopsy and diagnostic imaging device, Radiation therapy systems, Cancer detection IVDs

Ophthalmology

Biopsy and diagnostic imaging devices, Radiation therapy system, Cancer detection IVDs

Respiratory Care

Respiratory support systems, Inhalers and nebulizers, Sleep apnea management devices

Vision

To be a trusted global partner helping Medical Device and IVD manufacturers bring safe, compliant, and effective technologies to patients worldwide.

MISSION

To support Medical Device and IVD manufacturers with clinical evidence generation, regulatory compliance, and post-market readiness from development to global market access.

CORE VALUES

Regulatory Integrity: Clear, traceable, and audit-ready work. Quality First: Patient safety and compliance in every deliverable.Speed with Accuracy: Fast execution without compromising standards. Collaboration: Transparent, responsive partnership with clients. Continuous Improvement: Learn, refine, and strengthen outcomes.

Testimonials

What Clients Say About Us

“The Bioexcel team demonstrated strong technical competence in PMCF planning, execution, and reporting. Their commitment to timelines and data quality made them a dependable partner for our post-market compliance activities.”

Senior Management

Global Medical Device Company

“Bioexcel supported us with clinical and regulatory documentation efficiently and professionally. Their expertise in regulatory affairs and report preparation helped us progress smoothly through key milestones. We value their structured approach and responsiveness.”

Quality Manager Medical

Device Manufacturing Company

Working with Bioexcel on our post-market clinical follow-up (PMCF) activities was a seamless experience. Their strong understanding of regulatory expectations and proactive execution ensured timely and high-quality outcomes. Bioexcel proved to be a reliable and knowledgeable partner

Managing Director

European Medical Device Manufacturer

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