About Clinical Evaluation
Clinical evaluation is another “must” for all medical devices regardless of device classification (IVD excluded). A clinical evaluation is the assessment and analysis of clinical data needed to verify the clinical safety and performance of the device. It is important to write the clinical evaluation plan in time to estimate costs and to allow sufficient time for completion. A widely accepted method of clinical evaluation is to follow the European Commission Guidance MEDDEV 2.7.4. For the manufacturer clinical evaluation is often complex as it means compiling and analyzing all data needed to verify clinical safety and performance of the device. The clinical evaluation includes analysis of preclinical and clinical investigations, scientific literature and/or clinical experience with similar devices. When all available data is compiled it is possible to identify if further data is required, for example a clinical investigation.
Furthermore, in the post-market phase, the documentation should be kept up to date to reflect the clinical data available for the device. When further risks are identified it may result in, for example, a change of intended use or change to the labelling.
What Symbioteq can do
Symbioteq help companies to write the Clinical evaluation plan and report for world-wide submissions. Beside in-house competence, we have an extensive network and co-operate with specialists and contract organizations of various kinds around the world to obtain the required expertise needed. When a clinical investigation is needed we co-operate with sub-contractors specialized in clinical investigations. We are members of the standardization committee which allows us to continuously follow and also impact the standard development.
- Write the Clinical evaluation plan and report
- Perform Clinical literature reviews
- Coordinate Clinical investigations including CROs and regulatory bodies
- Write SOPs for the Clinical evaluation process including Clinical evaluation plan and report templates, be your discussion partner when setting up internal procedures
- In-house training