Medical device trials
Our experienced and specialized team helps take medical device designs from concept to market. HungaroTrial provides full-service clinical trials with regulatory consulting for MDR compliance and CE Mark acquisition.
We are devoted to effective collaboration with global innovators, developing new ways to improve patient lives. Many of our CRAs and Project Managers are dedicated to specific sites and investigators and have worked closely with them for over a decade. Accordingly, they know which sites and investigators are best suited to ensuring quality and rigor as you navigate clinical development.
We offer services across a broad spectrum of therapeutic areas, including Cardiovascular, Orthopedy, Gastroenterology and many others. Our experience lets us facilitate the complex clinical trials and provide customized solutions for medical device manufacturers.Selected experience list
Director of Medical Device Unit
Antal Solyom, MSc
14 years at Notified Body TUV Rheinland as Medical Device Expert
- 4 years as Lead Auditor and Medical Device Expert
- 2 years as LA in TUV Rheinland of North America in USA
- 8 years as Certifier and Head of Certification Office
3 years at Notified Body ORKI as Medical Device Expert and LA
Graduated as Mechanical Engineer MSc at University of Miskolc
Contact our Medical Device Team at
Explore how we lead our Sponsors to Success in Medical Device Development
Immunosupressant Eluting Stent Project
It was a large global clinical trial with the involvement of US, Japan and Europe. HungaroTrial completed the complex regulatory procedure within the planned timeline. There weren’t any regulatory complications.
The original enrollment target in HungaroTrial area was 20 patients. It was completed within 6 months. Sponsor increased the target to 30 patients. We closed the project with 36 patients – 180% of the original target.
Insulin pump project
The insulin pump is a medical device with CE mark used for the administration of insulin by a continuous insulin infusion in the abdominal subcutaneous area. The device includes a pump with control – processing programs and a battery, a sterile reservoir for insulin and a sterile infusion set to connect the subcutaneous area.
33 trial sites were involved into the project worldwide. However the enrolment rate was below target after 18 month. HungaroTrial was approached to rescue the study, and opened 2 new trial sites in Hungary and Serbia, which led to study completion.
Both HungaroTrial sites were in the TOP 5 enrolling sites!
Medical device study in Gastroesophageal Reflux Disease
A medical device study was completed in Bulgaria, Hungary and Serbia with a product used for gastro-oesophageal reflux surgery. The follow up period is still ongoing, but excellent efficacy results have been noted.
The successful study was a key element to ensure the product safety and efficacy based on the MDR requirement, in the conformity assessment procedure obtaining the CE mark.
Advance Your Program Today
HungaroTrial is ready to help you complete your clinical trial program on time and to the highest standards.
Clinical development / Phase I-IV. services
We provide exceptional study design, management, monitoring, and reporting expertise for our partners to support their confident decisions for successful clinical development. Our network in the medical community of the CEE Region and long-term KOL connections ensure optimal trial site selection and enrolment rates for our Clients.
For over 20 years HungaroTrial has provided CRA sourcing services in most CEE countries. The best proof of our service’s quality is the long list of our repeat clients, including 7 of the TOP 10 global pharmaceutical companies.
Support for COVID-19 research
From the beginning of the pandemic, HungaroTrial has been very active in COVID-19 clinical research. Our colleagues are dedicated to add our clinical development knowledge, medical expertise and research infrastructure to the global efforts to find safe and effective COVID-19 medications.