Regulations

To ensure best product and service standards following regulations are the basis of all our activities:

  • DIN EN ISO 9001                               
  • DIN EN ISO 13485
  • Medizinproduktegesetz (MPG)               
  • Directive 98/79/EC on in vitro diagnostics
  • Chemikaliengesetz (ChemG, incl. GLP)
  • RiLiBÄK

 

Depending on product/project requirements, laboratories of different standards are available:

S1, S2, L3**, clean room

from idea to product