Medical Device Clinical Trials

Service Overview

Medical Device Trial Expertise

Medical device clinical trials require a unique combination of regulatory expertise, specialised site capabilities and procedural precision. aCROss Medical has built a dedicated competency for medical device studies, working with sponsors across all device classes — from Class I investigational devices to Class III high-risk implantable systems.

Our investigative site network includes specialist surgical centres, interventional cardiology and radiology units, orthopaedic centres and ophthalmology clinics — all of which have the infrastructure and experience to handle complex device procedures in a GCP-compliant setting.

Device Trial Services

• Regulatory strategy and submission for device studies (CE, FDA IDE, local MoH)
• Site feasibility and selection for device-specific procedures
• Investigator training and device procedure qualification
• Clinical monitoring — on-site and remote
• Device accountability, storage and logistics management
• Adverse event and incident reporting per MDR/ISO 14155 requirements
• Post-market clinical follow-up (PMCF) study support
• Data management and biostatistics for device endpoints

Therapeutic Areas for Device Trials

aCROss Medical supports medical device trials across a broad range of specialties, with particular strength in:

• Cardiology — interventional devices, rhythm management, structural heart
• Orthopaedics — implants, joint replacement, bone repair systems
• Ophthalmology — intraocular lenses, surgical devices, diagnostic equipment
• Urology — minimally invasive devices, endoscopic systems
• Neurology — neuromodulation, cerebrovascular devices
• Wound care and skin devices — dressings, skin closure, tissue management

Why Choose Our Countries for Device Trials

Georgia, Armenia, Israel and Uzbekistan each offer distinct advantages for medical device studies. Israel in particular is a global centre of medical technology innovation, with world-class hospitals and experienced device trial investigators. Georgia and Armenia offer fast regulatory timelines and lower operational costs, making early-phase device studies highly cost-effective. Uzbekistan provides access to a large, treatment-naive patient pool for studies requiring specific patient demographics.

Regulatory Compliance

All medical device trials conducted through aCROss Medical adhere to ISO 14155:2020 (Good Clinical Practice for Medical Devices), ICH E6(R2) GCP, and applicable national regulatory requirements. Our regulatory team works closely with sponsors to ensure that submissions are complete, timelines are accurate and approvals are obtained efficiently.