EU clinical trials

Imdrf (International Forum of medical device regulators) defines medical device clinical trial as a systematic trial or study conducted in multiple subjects to evaluate the safety, clinical performance and / or effectiveness of medical devices. Clinical trials of medical devices include feasibility tests, tests carried out to obtain marketing approval, and tests carried out after being approved for marketing. Clinical trials of medical devices are an important part of medical device management. Major countries and regions in the world have issued relevant regulatory documents.

The new EU medical device regulation (MDR) and in vitro diagnostic device regulation (ivdr) are designed to ensure the safety of all medical device (MD) and in vitro diagnostic device (IVD) products and procedures. EU regulations on clinical trials of medical devices mainly include medical device regulation No. 2017 / 745 (EU), in vitro diagnostic medical device regulation No. 2017 / 746 (EU), EU medical device clinical evaluation meddev 2.7/1 Rev. 4 4 guiding principles, human subject clinical research of medical devices - clinical trial quality management specification (ISO 14155:2020), good research quality management specification for clinical performance research of in vitro diagnostic medical devices using human samples (ISO 20916:2019), etc. EU Member States make special provisions and application of GCP for medical devices according to their different requirements.

About biodomi

Biodomi is a contract research organization (CRO) operating in Europe. EU countries are attractive places for drug clinical trials and clinical evaluation of medical devices. The company's policy is based on the concept of win-win. We have established a trusted network of partners around the world, which can provide a wide range of high-quality clinical research services in many European countries. Today, our network includes about 40 partner companies. We manage a variety of clinical trial projects for our customers, ranging from simple to complex projects.

Biodomi's core business is large-scale non interventional research of clinical trials of medical devices and in vitro diagnostic reagents. The service covers all activities, from research design and development to the creation of final research reports. You can delegate any selected task or multinational clinical trial of the whole scale. We are happy to manage the project within biodomi or with other partners (cros). If biodomi does not provide certain tasks (e.g. logistics, insurance), we will subcontract a fully reviewed local European supplier to provide all the contents of the clinical trial from the whole process. Centralized project management makes it easy for our customers to experiment. A single point of contact, individual project managers and regular reports will make our cooperation efficient and well managed without your significant efforts.

Biodomi's clinical operations services include:

-Global feasibility study.

-Study initiation: site identification, qualification and selection.

-Contract management.

-Formulation and review of normative documents.

-Research document development.

-Train investigators.

-Basic document collection.

-Try master file setup and maintenance.

-On site monitoring and management (on-site and remote).

-Subject recruitment and retention.

-Training for clinical research team.

-Site startup, monitoring and shutdown.

-Field source data verification.

-Medical monitoring

-Sponsor contact.

-Audit preparation.

-IRB / Ca submits the application.

-Third party supplier management.

Our main goal is to provide you with the most suitable service for your needs, and make our service reasonable, save time and cost.

Contact us to discuss any questions or concerns you have.