Success Stories
Real Evidence. Real Impact.
Discover how Bioexcel partners with innovators across Medical Devices and IVDs to generate high-quality evidence and achieve regulatory success.
Urology Portfolio – EU MDR CER Nonconformity Resolution
A UK-based medical device sponsor with a portfolio of urology devices received Notified Body (NB) nonconformities agai…
Spinal Implant Systems – EU MDR PMCF Study (Class IIb)
Manufacturer of Class IIb spinal implant systems requiring real-world post-market evidence under EU MDR.
Clinical Investigation – Digital Thermometer (Class A, India)
To generate prospective clinical evidence supporting safety and performance under Indian MDR 2017.
Non-Invasive IOP Assessment Device – EU Clinical Investigation
Prospective evidence required to confirm safety and comparator-based performance alignment.
FDA Human Factors Validation – Hemoglobinometer (IVD)
FDA-aligned protocol review prior to Human Factors Validation Study.
Diagnostic Catheter – EU MDR Class III Clinical Investigation
Intracardiac electrophysiology diagnostic catheter (Class III).
Guiding Catheter – Interventional Cardiology (Class III)
Demonstrate safety, usability, and procedural performance.
Hemodialysis Catheters – Long & Short Term (Class III)
Demonstrate procedural and functional performance for extracorporeal therapy.
PMCF – Cemented Mobile Bearing Total Knee Replacement (Class III Implant)
15-year PMCF to confirm long-term implant survivorship and safety.
PMCF – Non-Absorbable Synthetic Surgical Sutures (Class IIb)
Confirm continued safety and performance in real-world surgical use.
CDSCO Import Licence (MD-15) – Indian Market Entry
Korean manufacturer entering India through an Authorized Agent & Wholesaler.
Evidence That Drives Regulatory Success
From study design to regulatory submission, our integrated approach helps innovators achieve compliance and improve patient outcomes.
Explore Our Services150+
Clinical Programs Delivered
10+
Countries Served
250+
Sites & Investigator Network
20+
Years of Clinical Research Excellence
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