Services
Clinical assessment strategy
As a Clinical Research Organisation (CRO) and as a specialist for clinical data, medXteam supports manufacturers of medical devices in the strategic planning, generation and evaluation of clinical data – from the first product idea to post-market surveillance.
Our focus is not solely on clinical trials, but on the entire clinical evidence for your product: from the planning and execution of clinical trials, if required, to clinical evaluation and its updates.
Every project begins with the development of a product-specific clinical data strategy. In our pre-project phase, we systematically analyze which clinical data are required for your medical device and how this data can be collected or used in a regulatory-efficient and economically viable manner.
In three structured steps, we will work with you to develop the optimal strategy for clinical data generation and evaluation:
Step 1: Evaluation
Evaluation of the product idea/existing product and existing clinical data
Step 2: GAP analysis
Identification of potential data gaps, taking into account MDR requirements, risk class and product characteristics
Step 3: Derivation of measures
Derivation of appropriate measures: selection of the right route for clinical evaluation, planning of a clinical trial, preparation of the initial/update clinical evaluation or PMCF activities
The result is a clear, regulatory-compliant and cost-efficient strategy that serves as a basis for all further activities related to your clinical data and can be optimally integrated into your development or market surveillance process.
The clinical evaluation process according to MEDDEV 2.7/1 Revision 4:
