FULL-SERVICE CLINICAL INVESTIGATION CONSULTANCY
Devicia provides full-service clinical investigation consultancy services to help you generate clinical data, both prior to and after market introduction of your medical device. Our team will help you to effectively integrate your clinical investigations into your go-to-market model. This includes all kinds of investigations, such as first-in-human studies, feasibility or pilot studies, randomized controlled clinical investigations, and registries.
Devicia’s aim is to provide services that enable your company to make patients benefit from your device as quickly and safely as possible. When working with us, you get access to a team that specializes exclusively in clinical investigations for medical devices.
Furthermore, our Quality Management System (QMS), based on ISO 14155, is specifically tailored to the requirements for clinical investigations of medical devices. When designing clinical investigations, we always consider the reimbursement landscape in order to make the device available to as many consumers as possible.
Our services include:
- Clinical Investigation Documentation (ISO 14155, MDD 93/42/EEC, MDR 2017/745, 21 CFR parts 50, 56, and 812) (CIP), Investigator’s Brochure (IB), Patient Information Sheet (PIS) and Informed Consent Form (ICF),
- EC/IEC/IRB and CA/RA submissions
- Study and Site Files
- Data Management
- Site Selection, Site Initiation and Close-out Visits
- Project Management
- Recruitment Material