Validation of medical devices and applications


Taking into account all approval requirements during product development.

For the application of medical devices you have to meet a whole set of legal and regulatory regulations.  The product and organizational requirements depend on the classification and applicable standards. The classification Class 1 to 3 depends on the  risk potential of the medical product.
Beginning with Class 2, in special cases also Class 1, the appointed external authority has to evaluate the conformity of the product. This is the condition for the CE mark on your products and the launching in the market.

Your special advantage:
We have ideal combined the different requirements of the EU and the USA. You obtain the approval for the EU and the USA with just one system.

Our Services:

  • Classification of your medical products  under EU and US directives 
  • Combination of the legal and regulatory requirements specifically tfor your product
  • Documentation under the above mentioned standards; product file, clinical tests, technical documentation following the EU / US requirements
  • Drafting the licensing strategy and selection of the suitable conformity evaluation procedure
  • Implementation and execution of risk management
  • Validation of your medical device in cooperation with reliable network partners (Physical, chemical and biomedical tests)
  • Execution of  formalities and communication with government institutions in Europe / USA.
  • Registration and listing of your medical devices
  • Basic requirements for medical devices
  • Product labelling
  • Monitoring and reporting system
  • Training of  your staff as medical product consultant or security representative  for medical products 
  • Organizational requirements for the approval of your product; ISO 9001/2000, ISO 13485 and in accordance to the requirements for the US-Good Manufacturing Practices (GMP) / Quality System (QS) Regulations. Please see also our efficiency in the quality management system


On top of all economic activites there is the market view. [more...]


The technical implementation requires clear development targets and efficient organizational structures. [more...]


Finance your idea. [more...]