We go theextra smile.
Clinical.
We support start-ups, large corporation, hospitals and governmental or research institutions in clinical research and real-world evidence generation for product development and clinical validity assessment. We help in defining the research and clinical strategy, performing literature review and competitive analysis, the clinical investigation plan, the clinical evaluation report, and evidence generation through peer-reviewed journal (success rate of >90%). We also help you to generate income through support for governmental grants applications. This includes the identification of the right calls, the drafting and re-writing of the grant, the identification of the right project partners, and the project management in case of funding.
We leverage our clinical expertise for your preliminary risk-benefit analysis, for your clinical evaluation plan and literature review, the clinical evaluation report or for the post-market clinical follow-up of your product. We help you with you full CE or FDA submission or IEC/ISO standards, together with regulatory experts.
Regulatory.
Medicalphysics.
Are you already compliant with the European Directive 2013/59/EURATOM and the KB of 20.02.2020 on medical exposure in Belgium? As recognized Medical Physics Experts, we give you advice on matters relating to radioprotection for medical exposure, evaluation and optimization of clinical protocols and performance of imaging assets, including technical advice for device purchasing and commissioning.
We also help you to deliver a quality healthcare professional education through training activities concerning the technical-scientific know-how supporting the clinically effective, safe, evidence-based use of medical devices.
