ClinOps Consulting is a Belgium based boutique consulting company, founded in 2008 by Tanja Stevens and Stefan Hosten, 2 senior profiles in the European clinical research world. Tanja and Stefan combine a +50 years of clinical research and +35 years of medical device experience.
Our mission is to combine a highly professional service with a strong commitment and a personal approach in medical device clinical research.
The expertise of both consultants is in senior clinical project management, field clinical support and strategic advice.
Senior Clinical Project Management
We offer senior management solutions for clinical projects in medical devices industry. We manage clinical projects in all their aspects, from study design, protocol and study document development, vendor selection and management, budget preparation, contracting, approvals & management oversight to full execution of projects in international context.
Field Clinical Engineering
ClinOps Consulting offers field support to technically prepare and support clinical programs (implanter training in office or wetlab, physician/staff and patient education, implanter support in OR/cathlab, programming of active implantables, etc…)
ClinOps Consulting offers support and advice on European regulations (ISO14155, MDD/MDR), strategic input to bring your Medical Devices to the market. We have a strong track record of guiding start-up companies with their clinical strategies.
Leadership to Research and Field Technical Teams
We lead clinical projects or programs and manage clinical and technical teams throughout the execution of the studies.