YOUR MEDICAL DEVICE CRO
BRIDGING THE US AND EU THROUGH MEDICAL DEVICE EXCLUSIVITY
Devicia is a clinical research organization (CRO) focused exclusively on medical devices. We support our clients with all aspects of medical and regulatory affairs. Devicia has extensive experience with EU and US medical device regulations. We create value for our clients by providing strategic input to maximize the usefulness of services including clinical investigations. Devicia’s main goal is to make new and innovative medical devices globally available to patients by helping clients shorten time-to-market through our EU and US medical device expertise.
ARE YOU PLANNING A CLINICAL INVESTIGATION IN THE EU?
Making sure to follow all applicable rules and regulations surrounding clinical investigations is not trivial. We can guide you through the entire process of planning, executing and ensuring you obtain maximal value from your clinical investigation. Devicia has the resources, systems, experience and professional network to generate precise clinical data and ensure time-to-market is predictable and efficient. We are dedicated to designing and conducting clinical investigations for medical devices.
PLANNING TO TRANSFER CLINICAL DATA OUTSIDE OF EUROPE?
As a sponsor you have the ultimate responsibility for the quality and integrity of the clinical investigation data. If the clinical investigation is subject to the General Data Protection Regulation 2016/679 (GDPR), detailed data privacy information must be provided to the participants and requirements regarding transfer of data must be considered. Devicia can help you navigate through these requirements.
EU REGULATORY TRANSIT
The EU regulatory framework surrounding medical devices is currently shifting and the medical device directives (MDD, AIMDD and IVDMD) are being replaced by regulations (MDR and IVDR). Thanks to our presence in the region, our participation in EU Technical committees, and our multidisciplinary expertise, we guide our clients through all transition activities and ensure that the transition is performed in a controlled and effective way.
GLOBAL CLINICAL STRATEGY
Due to the many similarities between medical device regulatory systems around the world, clearance or approval in one market can facilitate access to another. Additionally, many countries accept foreign clinical data in applications for market authorization. Based on our client’s target markets, we can develop a global Clinical Strategy to increase the predictability of a product's launch.
EU Medical Device Regulation (MDR) has been postponed until 26 May 2021 due to current Corona situat...
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