The clinical evaluation plays a key role in the certification and market launch, as well as in market observation.  

§19, section I of the medical product law and appendix X of the EU guidelines 93/42/EWG require that the suitability of all medical products be proven with respect to their designated use. According to MEDDEV guideline 2.7.1, the clinical evaluation of medical products may be based on data taken from scientific literature. In this case certain prerequisites apply, such as the technical equivalence to established and certified products.  The clinical evaluation of the further development of existing products can also, in many cases, be based on literature. In the event that our client’s products can be evaluated in this way, we provide the complete clinical evaluation. 

The clinical evaluation of our client’s medical product involves literary research of the relevant clinical and technical properties.  In doing so, we consult the following sources: 

  • publicized scientific literature
  • guidelines of professional societies and associations
  • informationen from governmental agencies
  • clinical data of the manufacturer and
  • unpublished data

We check the main product user documentation, including instructions for use, training documentation as well as risk management documentation.  
We analyze the properties of our customer’s product that are relevant for clinical use in the clinical context by researching and evaluating information taken from market observation by public agencies, from product registries and from comparisons with competitive and technically related products. 
Based on this research, we conduct a neutral evaluation of the clinical advantages of our client’s product, its applications, risks and hazards. Our client receives the results of the clinical evaluation including the complete documentation.  With our systematic approach, clinical evaluations can be extended to cover further developments of existing products.  We thus provide customer-oriented solutions as well as quick and competent support in all matters of clinical product evaluation. 
We are certified to do pre-clinical and clinical contract research in the field of medical technology according to ISO 9001 and are audited regularly by DEKRA Certification GmbH.  Further information regarding clinical evaluation can be found at the following site: